510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K910741Substantially Equivalent

Heparin Controls, High and Low

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

K910741 is the FDA 510(k) clearance record for HEPARIN CONTROLS, HIGH AND LOW, a class II device, cleared for Sigma Diagnostics, Inc. on under FDA product code KFF (Assay, Heparin). FDA records list 164 510(k) clearances for Sigma Diagnostics, Inc., from to . As of , FDA records show no recalls naming K910741.

Clearance record

Decision date
Received
(67 days to decision)
Product code
KFF Assay, Heparin
Regulation
21 CFR 864.7525
Device class
Class II
Review panel
Hematology
Applicant
Sigma Diagnostics, Inc. 545 S. Ewing Ave., St. Louis MO
Third party review
No

Clearances, product code KFF

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