510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K861973Substantially Equivalent

D-Di Test Kit

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

K861973 is the FDA 510(k) clearance record for D-DI TEST KIT, a class II device, cleared for American Bioproducts Co. on under FDA product code GHH (Fibrin Split Products). FDA records list 79 510(k) clearances for American Bioproducts Co., from to . As of , FDA records show no recalls naming K861973.

Clearance record

Decision date
Received
(106 days to decision)
Product code
GHH Fibrin Split Products
Regulation
21 CFR 864.7320
Device class
Class II
Review panel
Hematology
Applicant
American Bioproducts Co. 601 N. Jefferson Rd., Parsippany NJ
Third party review
No

Clearances, product code GHH

Trailing 12 months

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

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