510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K842862Substantially Equivalent

Cb Formalin

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

K842862 is the FDA 510(k) clearance record for CB FORMALIN, a class I device, cleared for Anatech, Ltd. on under FDA product code IGE (Solution, Formalin Ammonium Bromide). FDA records list 14 510(k) clearances for Anatech, Ltd., from to . As of , FDA records show no recalls naming K842862.

Clearance record

Decision date
Received
(36 days to decision)
Product code
IGE Solution, Formalin Ammonium Bromide
Regulation
21 CFR 864.4010
Device class
Class I
Review panel
Pathology
Applicant
Anatech, Ltd. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code IGE

Trailing 12 months

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

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