OPUS TOTAL CK— 510(k) K933675

Substantially Equivalent

Pb Diagnostic Systems, Inc.

FDA 510(k) clearance K933675 for OPUS TOTAL CK, Substantially Equivalent on 1993-09-08. Applicant: Pb Diagnostic Systems, Inc.. Device class: 2.

Clearance details

Applicant: Pb Diagnostic Systems, Inc.
Product code: Code CGS
Device class: Class 2
Regulation: 21 CFR 862.1215
Advisory panel: Clinical Chemistry
Date received: 1993-07-28
Decision date: 1993-09-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Westwood, MA, US

Download summary PDF View on FDA.gov ↗

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