510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K992711Substantially Equivalent

Sigma Diagnostics Alexin Hs, Models A0969, A1094

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

K992711 is the FDA 510(k) clearance record for SIGMA DIAGNOSTICS ALEXIN HS, MODELS A0969, A1094, a class II device, cleared for Sigma Diagnostics, Inc. on under FDA product code GFO (Activated Partial Thromboplastin). FDA records list 164 510(k) clearances for Sigma Diagnostics, Inc., from to . As of , FDA records show no recalls naming K992711.

Clearance record

Decision date
Received
(117 days to decision)
Product code
GFO Activated Partial Thromboplastin
Regulation
21 CFR 864.7925
Device class
Class II
Review panel
Hematology
Applicant
Sigma Diagnostics, Inc. 545 S. Ewing Ave., St. Louis MO
510(k) summary
Summary
Third party review
No

Clearances, product code GFO

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