OPUS(R) CK-MB— 510(k) K924429

Substantially Equivalent

Pb Diagnostic Systems, Inc.

FDA 510(k) clearance K924429 for OPUS(R) CK-MB, Substantially Equivalent on 1992-10-15. Applicant: Pb Diagnostic Systems, Inc.. Device class: 2.

Clearance details

Applicant: Pb Diagnostic Systems, Inc.
Product code: Code JHY
Device class: Class 2
Regulation: 21 CFR 862.1215
Advisory panel: Clinical Chemistry
Date received: 1992-09-01
Decision date: 1992-10-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Westwood, MA, US

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