510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K812570Substantially Equivalent

Labcer Fibrinogen Assay Kit & Calibr.

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

K812570 is the FDA 510(k) clearance record for LABCER FIBRINOGEN ASSAY KIT & CALIBR., a class II device, cleared for Sherwood Medical Co. on under FDA product code KQJ (System, Fibrinogen Determination). FDA records list 191 510(k) clearances for Sherwood Medical Co., from to . As of , FDA records show no recalls naming K812570.

Clearance record

Decision date
Received
(23 days to decision)
Product code
KQJ System, Fibrinogen Determination
Regulation
21 CFR 864.7340
Device class
Class II
Review panel
Hematology
Applicant
Sherwood Medical Co. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code KQJ

Trailing 12 months

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

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