510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K900412Substantially Equivalent

Factor XII Deficient Plasma

Sigma Chemical Co., St. Louis MO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K900412 is the FDA 510(k) clearance record for FACTOR XII DEFICIENT PLASMA, a class II device, cleared for Sigma Chemical Co. on under FDA product code GJT (Plasma, Coagulation Factor Deficient). FDA records list 231 510(k) clearances for Sigma Chemical Co., from to . As of , FDA records show no recalls naming K900412.

Clearance record

Decision date
Received
(36 days to decision)
Product code
GJT Plasma, Coagulation Factor Deficient
Regulation
21 CFR 864.7290
Device class
Class II
Review panel
Hematology
Applicant
Sigma Chemical Co. 545 S. Ewing Ave., St. Louis MO
Third party review
No

Clearances, product code GJT

Trailing 12 months

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

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