510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K000527Substantially Equivalent

Accuclot Drvvt Screen, Catalog No. A6094

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

K000527 is the FDA 510(k) clearance record for ACCUCLOT DRVVT SCREEN, CATALOG NO. A6094, a class I device, cleared for Sigma Diagnostics, Inc. on under FDA product code GIR (Reagent, Russel Viper Venom). FDA records list 164 510(k) clearances for Sigma Diagnostics, Inc., from to . As of , FDA records show no recalls naming K000527.

Clearance record

Decision date
Received
(50 days to decision)
Product code
GIR Reagent, Russel Viper Venom
Regulation
21 CFR 864.8950
Device class
Class I
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 GIR

Trailing 12 months

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

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