510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K821443Substantially Equivalent

Formical

Lerner Laboratories, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K821443 is the FDA 510(k) clearance record for FORMICAL, a class I device, cleared for Lerner Laboratories, Inc. on under FDA product code KDX (Solution, Decalcifier, Acid Containing). FDA records list 5 510(k) clearances for Lerner Laboratories, Inc., from to . As of , FDA records show no recalls naming K821443.

Clearance record

Decision date
Received
(19 days to decision)
Product code
KDX Solution, Decalcifier, Acid Containing
Regulation
21 CFR 864.4010
Device class
Class I
Review panel
Pathology
Applicant
Lerner Laboratories, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code KDX

Trailing 12 months

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

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