510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K871976Substantially Equivalent

Multichem Glucose Hexokinase Reagent #S0919

Simmler Inc, St. Louis MO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K871976 is the FDA 510(k) clearance record for MULTICHEM GLUCOSE HEXOKINASE REAGENT #S0919, a class II device, cleared for Simmler, Inc. on under FDA product code CFR (Hexokinase, Glucose). FDA records list 23 510(k) clearances for Simmler, Inc., from to . As of , FDA records show no recalls naming K871976.

Clearance record

Decision date
Received
(14 days to decision)
Product code
CFR Hexokinase, Glucose
Regulation
21 CFR 862.1345
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Simmler, Inc. Post Office Box 25179, St. Louis MO
Third party review
No

Clearances, product code CFR

Trailing 12 months
1 clearance under product code CFR in the twelve months to October 2026, February 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code CFR, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20261
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260