ROCHE UNIMATE HDL DIRECT REAGEN (WITH POL CLAIM)— 510(k) K973369

Substantially Equivalent

Roche Diagnostic Systems, Inc.

FDA 510(k) clearance K973369 for ROCHE UNIMATE HDL DIRECT REAGEN (WITH POL CLAIM), Substantially Equivalent on 1997-11-21. Applicant: Roche Diagnostic Systems, Inc..

Clearance details

Applicant: Roche Diagnostic Systems, Inc.
Product code: Code LBR
Advisory panel: Clinical Chemistry
Date received: 1997-09-08
Decision date: 1997-11-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Somerville, NJ, US

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