N = Not Eligible for Accredited Persons Program
P = Eligible for Accredited Persons Expansion Pilot Program
Y = Eligible for Accredited Persons Program
AN De Novo Petitions Granted
CR Additional Information Requested; Applicant can not respond within 30 days
CS Substantially Equivalent - CLIA Submission
DB Forwarded to Drugs/Biologics
DD Deleted/Duplicate
DE Deleted
DR Drug (CDER) Review Required
EX Exempted by Regulation
FB Subject to 515(b) - Requires PMA
GP General Purpose Article
Old? Typo? Substantively Equivalent?
K4 Closeout Letter Issued
KD Substantially Equivalent - Kit with Drugs
NA Not Actively Regulated
ND Not a Device
NE Not Substantially Equivalent
NF Not a Finished Product
NR Not a Required Submission
OD Unable to Determine Equivalence - Outstanding Device Issue
PE Preamendment Exempt
PR Substantially Equivalent - Proposed Recision
PT Substantially Equivalent - Subject to Tracking & PMS
RC Reconditioner/Remanufacturer
RE Rescind Substantial Equivalence
RN Substantially Equivalent - Rescind Non-Substantial Equivalence
SA Substantially Equivalent - Awaiting Device Approval
SC Not Substantially Equivalent - Cannot Market
SD Substantially Equivalent with Drug
SE Substantially Equivalent
SF Substantially Equivalent - Awaiting Future Policies
SI Substantially Equivalent - Market after Inspection
SK Substantially Equivalent - Kit
SL Not Substantially Equivalent - Improper Label
SN Substantially Equivalent for Some Indications
SP Substantially Equivalent - PostMarket Surveillance Required
ST Substantially Equivalent - Subject to Tracking Reg.
SU Substantially Equivalent - With Limitations
SW Substantially Equivalent - Awaiting Drug Approval
TR Transitional Device
UD Unable to Determine Equivalence
UO Unable to Determine Equivalence - Outstanding Drug Issue
UR Not Substantially Equivalent - Unreliable Data
WD Withdrawn by Applicant
DENG Decision granted
SEKD Substantially Equivalent
SESD Substantially Equivalent - Substantially Equivalent with Drug
SESE Substantially Equivalent - Substantially Equivalent
SESK Substantially Equivalent - Substantially Equivalent - Kit
SESP Substantially Equivalent - Substantially Equivalent - PostMarket Surveillance Required
SESU Substantially Equivalent - Substantially Equivalent - With Limitations
Anesthesiology Part 868 AN
Clinical Chemistry Part 862 CH
Cardiovascular Part 870 CV
Dental Part 872 DE
Ear, Nose, & Throat Part 874 EN
Gastroenterology & Urology Part 876 GU
Hematology Part 864 HE
General Hospital Part 880 HO
Immunology Part 866 IM
Molecular Genetics MG
Microbiology Part 866 MI
Neurology Part 882 NE
Obstetrics/Gynecology Part 884 OB
Ophthalmic Part 886 OP
Orthopedic Part 888 OR
Pathology Part 864 PA
Physical Medicine Part 890 PM
Radiology Part 892 RA
Substantially Equivalent SE
General & Plastic Surgery Part 878 SU
Clinical Toxicology Part 862 TX
Summary SESE