TRACE REAGENT LINE FOR THE COBAS MIRA— 510(k) K973869

Substantially Equivalent

Trace America, Inc.

FDA 510(k) clearance K973869 for TRACE REAGENT LINE FOR THE COBAS MIRA, Substantially Equivalent on 1998-01-07. Applicant: Trace America, Inc..

Clearance details

Applicant: Trace America, Inc.
Product code: Code CKA
Advisory panel: Clinical Chemistry
Date received: 1997-09-24
Decision date: 1998-01-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami, FL, US

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