510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K851649Substantially Equivalent

Apo a-I Immunoassay Test Set for Apolipoprotein A1

Photec Diagnostics, Inc., Little Falls NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K851649 is the FDA 510(k) clearance record for APO A-I IMMUNOASSAY TEST SET FOR APOLIPOPROTEIN A1, a class II device, cleared for Photec Diagnostics, Inc. on under FDA product code DER (Alpha-1-Lipoprotein, Antigen, Antiserum, Control). FDA records list 12 510(k) clearances for Photec Diagnostics, Inc., from to . As of , FDA records show no recalls naming K851649.

Clearance record

Decision date
Received
(44 days to decision)
Product code
DER Alpha-1-Lipoprotein, Antigen, Antiserum, Control
Regulation
21 CFR 866.5580
Device class
Class II
Review panel
Immunology
Applicant
Photec Diagnostics, Inc. 101 E. Main St., Little Falls NJ
Third party review
No

Clearances, product code DER

Trailing 12 months

FDA records hold no clearances under product code DER in the trailing twelve months.

FDA records show no clearances under product code DER in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DER, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260