PHADEBACT MONOCLONAL GC OMNI TEST— 510(k) K851650

Name: FDA 510(k) clearance K851650
Creator: U.S. Food and Drug Administration
Published: 1985-07-12

Substantially Equivalent

Pharmacia, Inc.

FDA 510(k) clearance K851650 for PHADEBACT MONOCLONAL GC OMNI TEST, Substantially Equivalent on 1985-07-12. Applicant: Pharmacia, Inc.. Device class: 2.

Clearance details

Applicant: Pharmacia, Inc.
Product code: Code LIC
Device class: Class 2
Regulation: 21 CFR 866.3390
Advisory panel: Microbiology
Date received: 1985-04-22
Decision date: 1985-07-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Piscataway, NJ, US

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