OPUS(R) ANTI CMV-M— 510(k) K913080

Substantially Equivalent

Pb Diagnostics, Inc.

FDA 510(k) clearance K913080 for OPUS(R) ANTI CMV-M, Substantially Equivalent on 1991-10-28. Applicant: Pb Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Pb Diagnostics, Inc.
Product code: Code LKQ
Device class: Class 2
Regulation: 21 CFR 866.3175
Advisory panel: Microbiology
Date received: 1991-07-11
Decision date: 1991-10-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Westwood, MA, US

Download summary PDF View on FDA.gov ↗

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