OPUS FSH— 510(k) K911409

Substantially Equivalent

Pb Diagnostic Systems, Inc.

FDA 510(k) clearance K911409 for OPUS FSH, Substantially Equivalent on 1991-04-16. Applicant: Pb Diagnostic Systems, Inc.. Device class: 1.

Clearance details

Applicant: Pb Diagnostic Systems, Inc.
Product code: Code CGJ
Device class: Class 1
Regulation: 21 CFR 862.1300
Advisory panel: Clinical Chemistry
Date received: 1991-04-01
Decision date: 1991-04-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Westwood, MA, US

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