510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K822733Substantially Equivalent

Sigma Reagent System No. 885

Sigma Chemical Co., Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K822733 is the FDA 510(k) clearance record for SIGMA REAGENT SYSTEM NO. 885, a class II device, cleared for Sigma Chemical Co. on under FDA product code JBE (Cell Enzymes (Erythrocytic And Leukocytic)). FDA records list 231 510(k) clearances for Sigma Chemical Co., from to . As of , FDA records show no recalls naming K822733.

Clearance record

Decision date
Received
(86 days to decision)
Product code
JBE Cell Enzymes (Erythrocytic And Leukocytic)
Regulation
21 CFR 864.7100
Device class
Class II
Review panel
Hematology
Applicant
Sigma Chemical Co. 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code JBE

Trailing 12 months

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

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