OPUS CMV TEST SYSTEM— 510(k) K905257

Name: FDA 510(k) clearance K905257
Creator: U.S. Food and Drug Administration
Published: 1991-04-17

Substantially Equivalent

Pb Diagnostic Systems, Inc.

FDA 510(k) clearance K905257 for OPUS CMV TEST SYSTEM, Substantially Equivalent on 1991-04-17. Applicant: Pb Diagnostic Systems, Inc.. Device class: 2.

Clearance details

Applicant: Pb Diagnostic Systems, Inc.
Product code: Code LIN
Device class: Class 2
Regulation: 21 CFR 866.3175
Advisory panel: Microbiology
Date received: 1990-11-21
Decision date: 1991-04-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Westwood, MA, US

Download summary PDF View on FDA.gov ↗

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