510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K041619Substantially Equivalent

Bio Check Whole Blood/plasma/sermon Model #801116

BioCheck Inc, Northridge CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K041619 is the FDA 510(k) clearance record for BIO CHECK WHOLE BLOOD/PLASMA/SERMON MODEL #801116, a class II device, cleared for Biocheck, Inc. on under FDA product code MMI (Immunoassay Method, Troponin Subunit). FDA records list 14 510(k) clearances for Biocheck, Inc., from to . As of , FDA records show no recalls naming K041619.

Clearance record

Decision date
Received
(185 days to decision)
Product code
MMI Immunoassay Method, Troponin Subunit
Regulation
21 CFR 862.1215
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Biocheck, Inc. 9418 Lasaine Ave., Northridge CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MMI

Trailing 12 months
1 clearance under product code MMI in the twelve months to October 2026, June 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code MMI, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20261
July 20260
August 20260
September 20260
October 20260