510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K063243Substantially Equivalent

Vidas Troponin I Ultra (Tniu) Assay, Model 30 448

bioMerieux, Inc., Hazelwood MO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K063243 is the FDA 510(k) clearance record for VIDAS TROPONIN I ULTRA (TNIU) ASSAY, MODEL 30 448, a class II device, cleared for bioMerieux, Inc. on under FDA product code MMI (Immunoassay Method, Troponin Subunit). FDA records list 408 510(k) clearances for bioMerieux, Inc., from to . As of , FDA records show no recalls naming K063243.

Clearance record

Decision date
Received
(414 days to decision)
Product code
MMI Immunoassay Method, Troponin Subunit
Regulation
21 CFR 862.1215
Device class
Class II
Review panel
Clinical Chemistry
Applicant
bioMerieux, Inc. 595 Anglum Dr., Hazelwood MO
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 November 2026, June 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code MMI, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20261
July 20260
August 20260
September 20260
October 20260
November 20260