510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K840926Substantially Equivalent

Formalin Solution 10% Neutral Buffer

Sigma Chemical Co., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K840926 is the FDA 510(k) clearance record for FORMALIN SOLUTION 10% NEUTRAL BUFFER, a class I device, cleared for Sigma Chemical Co. on under FDA product code IFP (Formalin, Neutral Buffered). FDA records list 231 510(k) clearances for Sigma Chemical Co., from to . As of , FDA records show no recalls naming K840926.

Clearance record

Decision date
Received
(10 days to decision)
Product code
IFP Formalin, Neutral Buffered
Regulation
21 CFR 864.4010
Device class
Class I
Review panel
Pathology
Applicant
Sigma Chemical Co. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code IFP

Trailing 12 months

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

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