510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K952338Substantially Equivalent

Sta-Coag Control [P] Plus Kit

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

K952338 is the FDA 510(k) clearance record for STA-COAG CONTROL [P] PLUS KIT, a class II device, cleared for American Bioproducts Co. on under FDA product code GGC (Control, Plasma, Abnormal). FDA records list 79 510(k) clearances for American Bioproducts Co., from to . As of , FDA records show no recalls naming K952338.

Clearance record

Decision date
Received
(125 days to decision)
Product code
GGC Control, Plasma, Abnormal
Regulation
21 CFR 864.5425
Device class
Class II
Review panel
Hematology
Applicant
American Bioproducts Co. 5 Century Dr., Parisppany NJ
510(k) summary
Summary
Third party review
No

Clearances, product code GGC

Trailing 12 months

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

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