MACRA LP(A) ENZYME IMMUNOASSAY KIT— 510(k) K992665

Name: FDA 510(k) clearance K992665
Creator: U.S. Food and Drug Administration
Published: 1999-11-26

Substantially Equivalent

Trinity Biotech USA

FDA 510(k) clearance K992665 for MACRA LP(A) ENZYME IMMUNOASSAY KIT, Substantially Equivalent on 1999-11-26. Applicant: Trinity Biotech USA. Device class: 2.

Clearance details

Applicant: Trinity Biotech USA
Product code: Code DFC
Device class: Class 2
Regulation: 21 CFR 866.5600
Advisory panel: Immunology
Date received: 1999-08-09
Decision date: 1999-11-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jamestown, NY, US

Download summary PDF View on FDA.gov ↗

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