OPUS SEROLOGY CONTROLS— 510(k) K925703

Substantially Equivalent

Pb Diagnostics, Inc.

FDA 510(k) clearance K925703 for OPUS SEROLOGY CONTROLS, Substantially Equivalent on 1993-04-08. Applicant: Pb Diagnostics, Inc..

Clearance details

Applicant: Pb Diagnostics, Inc.
Product code: Code MJX
Advisory panel: Clinical Chemistry
Date received: 1992-11-12
Decision date: 1993-04-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Westwood, MA, US

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