510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K864074Substantially Equivalent

Elastic Stain

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

K864074 is the FDA 510(k) clearance record for ELASTIC STAIN, a class I device, cleared for Sigma Diagnostics, Inc. on under FDA product code IAC (Van Gieson'S Stain). FDA records list 164 510(k) clearances for Sigma Diagnostics, Inc., from to . As of , FDA records show no recalls naming K864074.

Clearance record

Decision date
Received
(9 days to decision)
Product code
IAC Van Gieson'S Stain
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 IAC

Trailing 12 months

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

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