510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K943225Substantially Equivalent

Coamatic Factor VIII

Pharmacia Hepar, Inc., Franklin OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K943225 is the FDA 510(k) clearance record for COAMATIC FACTOR VIII, a class II device, cleared for Pharmacia Hepar, Inc. on under FDA product code GGP (Test, Qualitative And Quantitative Factor Deficiency). FDA records list one 510(k) clearance for Pharmacia Hepar, Inc. As of , FDA records show no recalls naming K943225.

Clearance record

Decision date
Received
(488 days to decision)
Product code
GGP Test, Qualitative And Quantitative Factor Deficiency
Regulation
21 CFR 864.7290
Device class
Class II
Review panel
Hematology
Applicant
Pharmacia Hepar, Inc. 160 Industrial Dr., Franklin OH
510(k) summary
Statement
Third party review
No

Clearances, product code GGP

Trailing 12 months

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

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