TINA-QUANT MYOGLOBIN GEN.2 TEST SYSTEM— 510(k) K061683

Name: FDA 510(k) clearance K061683
Creator: U.S. Food and Drug Administration
Published: 2006-07-21

Substantially Equivalent

Roche Diagnostics Corp.

FDA 510(k) clearance K061683 for TINA-QUANT MYOGLOBIN GEN.2 TEST SYSTEM, Substantially Equivalent on 2006-07-21. Applicant: Roche Diagnostics Corp.. Device class: 2.

Clearance details

Applicant: Roche Diagnostics Corp.
Product code: Code DDR
Device class: Class 2
Regulation: 21 CFR 866.5680
Advisory panel: Immunology
Date received: 2006-06-15
Decision date: 2006-07-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K061683

K-number listed on FDA's recall record

Z-2445-2019 — The Tina-Quant Myoglobin Gen. 2 Tests system is an immuno-turbidimetric assay for the quantitative in vitro determination of myoglobin in human serum and plasma on Roche automated clinical chemistry analyzersClass II·Terminated·Roche Diagnostics Operations, Inc.·20190702

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K061683.

Data sourced from openFDA. This site is unofficial and independent of the FDA.