OPUS(R) LH TEST SYSTEM— 510(k) K913938

Name: FDA 510(k) clearance K913938
Creator: U.S. Food and Drug Administration
Published: 1991-11-07

Substantially Equivalent

Pb Diagnostic Systems, Inc.

FDA 510(k) clearance K913938 for OPUS(R) LH TEST SYSTEM, Substantially Equivalent on 1991-11-07. Applicant: Pb Diagnostic Systems, Inc.. Device class: 1.

Clearance details

Applicant: Pb Diagnostic Systems, Inc.
Product code: Code CEP
Device class: Class 1
Regulation: 21 CFR 862.1485
Advisory panel: Clinical Chemistry
Date received: 1991-09-03
Decision date: 1991-11-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Westwood, MA, US

Download summary PDF View on FDA.gov ↗

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