510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K803054Substantially Equivalent

Saf Fixative

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

K803054 is the FDA 510(k) clearance record for SAF FIXATIVE, a class I device, cleared for Remel Co. on under FDA product code IGB (Solution, Formalin-Sodium Acetate). FDA records list 51 510(k) clearances for Remel Co., from to . As of , FDA records show no recalls naming K803054.

Clearance record

Decision date
Received
(20 days to decision)
Product code
IGB Solution, Formalin-Sodium Acetate
Regulation
21 CFR 864.4010
Device class
Class I
Review panel
Pathology
Applicant
Remel Co. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code IGB

Trailing 12 months

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

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