510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K001403Substantially Equivalent

Sigma Diagnostics Infinity Glucose Reagent, Models 17-25, 17-100P, 17-500P, 17-2000P, 18-20, 18-100P

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

K001403 is the FDA 510(k) clearance record for SIGMA DIAGNOSTICS INFINITY GLUCOSE REAGENT, MODELS 17-25, 17-100P, 17-500P, 17-2000P, 18-20, 18-100P, a class II device, cleared for Sigma Diagnostics, Inc. on under FDA product code CFR (Hexokinase, Glucose). FDA records list 164 510(k) clearances for Sigma Diagnostics, Inc., from to . As of , FDA records show no recalls naming K001403.

Clearance record

Decision date
Received
(99 days to decision)
Product code
CFR Hexokinase, Glucose
Regulation
21 CFR 862.1345
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Sigma Diagnostics, Inc. 545 S. Ewing Ave., St. Louis MO
510(k) summary
Summary
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