QUANTECH CK-MB ASSAY— 510(k) K984433

Substantially Equivalent

Quantech , Ltd.

FDA 510(k) clearance K984433 for QUANTECH CK-MB ASSAY, Substantially Equivalent on 1999-11-01. Applicant: Quantech , Ltd..

Clearance details

Applicant: Quantech , Ltd.
Product code: Code MYT
Advisory panel: Clinical Chemistry
Date received: 1998-12-14
Decision date: 1999-11-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Northridge, CA, US

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