510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K854384Substantially Equivalent

Asserachrom Fpa Kit

American Bioproducts Co., Parsippany NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K854384 is the FDA 510(k) clearance record for ASSERACHROM FPA KIT, a class II device, cleared for American Bioproducts Co. on under FDA product code DAN (Fibrinopeptide A, Antigen, Antiserum, Control). FDA records list 79 510(k) clearances for American Bioproducts Co., from to . As of , FDA records show no recalls naming K854384.

Clearance record

Decision date
Received
(97 days to decision)
Product code
DAN Fibrinopeptide A, Antigen, Antiserum, Control
Regulation
21 CFR 866.5350
Device class
Class II
Review panel
Immunology
Applicant
American Bioproducts Co. 601 N. Jefferson Rd., Parsippany NJ
Third party review
No

Clearances, product code DAN

Trailing 12 months

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

FDA records show no clearances under product code DAN in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DAN, 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