OPUS(R) SEROLOGY CONTROLS, MODIFICATION— 510(k) K934137

Substantially Equivalent

Pb Diagnostic Systems, Inc.

FDA 510(k) clearance K934137 for OPUS(R) SEROLOGY CONTROLS, MODIFICATION, Substantially Equivalent on 1994-03-07. Applicant: Pb Diagnostic Systems, Inc..

Clearance details

Applicant: Pb Diagnostic Systems, Inc.
Product code: Code MJX
Advisory panel: Clinical Chemistry
Date received: 1993-08-25
Decision date: 1994-03-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Westwood, MA, US

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