OPUS CMV-G— 510(k) K933389

Substantially Equivalent

Pb Diagnostic Systems, Inc.

FDA 510(k) clearance K933389 for OPUS CMV-G, Substantially Equivalent on 1994-06-28. Applicant: Pb Diagnostic Systems, Inc.. Device class: 2.

Clearance details

Applicant: Pb Diagnostic Systems, Inc.
Product code: Code LFZ
Device class: Class 2
Regulation: 21 CFR 866.3175
Advisory panel: Microbiology
Date received: 1993-07-12
Decision date: 1994-06-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Westwood, MA, US

Download summary PDF View on FDA.gov ↗

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More clearances from Pb Diagnostic Systems, Inc.

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K935229 — OPUS DIGITOXIN1993-12-22
K934705 — OPUS NAPA1993-11-22

Data sourced from openFDA. This site is unofficial and independent of the FDA.