510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K864531Substantially Equivalent

Tissue Gram Stain

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

K864531 is the FDA 510(k) clearance record for TISSUE GRAM STAIN, a class I device, cleared for Sigma Diagnostics, Inc. on under FDA product code ICF (Crystal Violet For Histology). FDA records list 164 510(k) clearances for Sigma Diagnostics, Inc., from to . As of , FDA records show no recalls naming K864531.

Clearance record

Decision date
Received
(35 days to decision)
Product code
ICF Crystal Violet For Histology
Regulation
21 CFR 864.1850
Device class
Class I
Review panel
Hematology
Applicant
Sigma Diagnostics, Inc. P.O. Box 14508, St. Louis MO
Third party review
No

Clearances, product code ICF

Trailing 12 months

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

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