OPUS(R) PLUS ANALYZER— 510(k) K913295

Name: FDA 510(k) clearance K913295
Creator: U.S. Food and Drug Administration
Published: 1991-09-11

Substantially Equivalent

Pb Diagnostic Systems, Inc.

FDA 510(k) clearance K913295 for OPUS(R) PLUS ANALYZER, Substantially Equivalent on 1991-09-11. Applicant: Pb Diagnostic Systems, Inc.. Device class: 1.

Clearance details

Applicant: Pb Diagnostic Systems, Inc.
Product code: Code JJQ
Device class: Class 1
Regulation: 21 CFR 862.2300
Advisory panel: Clinical Chemistry
Date received: 1991-07-24
Decision date: 1991-09-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Westwood, MA, US

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