510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K904022Substantially Equivalent

Nitro Blue Tetrazolium Reduction

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

K904022 is the FDA 510(k) clearance record for NITRO BLUE TETRAZOLIUM REDUCTION, a class I device, cleared for Sigma Chemical Co. on under FDA product code GHD (Test, Leukocyte Alkaline Phosphatase). FDA records list 231 510(k) clearances for Sigma Chemical Co., from to . As of , FDA records show no recalls naming K904022.

Clearance record

Decision date
Received
(110 days to decision)
Product code
GHD Test, Leukocyte Alkaline Phosphatase
Regulation
21 CFR 864.7660
Device class
Class I
Review panel
Hematology
Applicant
Sigma Chemical Co. 545 S. Ewing Ave., St. Louis MO
Third party review
No

Clearances, product code GHD

Trailing 12 months

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

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