510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K062838Substantially Equivalent

Vitros Troponin I Es Assay, Including Reagent Pack, Calibrators and Range Verifiers, Models 680 2301, 2302 and 2303

Ortho-Clinical Diagnostics, Inc., Rochester NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K062838 is the FDA 510(k) clearance record for VITROS TROPONIN I ES ASSAY, INCLUDING REAGENT PACK, CALIBRATORS AND RANGE VERIFIERS, MODELS 680 2301, 2302 AND 2303, a class II device, cleared for Ortho-Clinical Diagnostics on under FDA product code MMI (Immunoassay Method, Troponin Subunit). FDA records list 311 510(k) clearances for Ortho-Clinical Diagnostics, from to . As of , FDA records show 2 recalls naming K062838.

Clearance record

Decision date
Received
(89 days to decision)
Product code
MMI Immunoassay Method, Troponin Subunit
Regulation
21 CFR 862.1215
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Ortho-Clinical Diagnostics 100 Indigo Creek Dr., Rochester NY
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