510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K020109Substantially Equivalent

Sigma Diagnostics Accuclot La Control

Sigma Diagnostics, Inc., St. Louis MO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K020109 is the FDA 510(k) clearance record for SIGMA DIAGNOSTICS ACCUCLOT LA CONTROL, a class II device, cleared for Sigma Diagnostics, Inc. on under FDA product code GGC (Control, Plasma, Abnormal). FDA records list 164 510(k) clearances for Sigma Diagnostics, Inc., from to . As of , FDA records show no recalls naming K020109.

Clearance record

Decision date
Received
(26 days to decision)
Product code
GGC Control, Plasma, Abnormal
Regulation
21 CFR 864.5425
Device class
Class II
Review panel
Hematology
Applicant
Sigma Diagnostics, Inc. 545 S. Ewing Ave., St. Louis MO
510(k) summary
Summary PDF
Third party review
No

Clearances, product code GGC

Trailing 12 months

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

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