GEMTAB SYSTEM— 510(k) K894503

Substantially Equivalent

Pharmacia Eni Diagnostics, Inc.

FDA 510(k) clearance K894503 for GEMTAB SYSTEM, Substantially Equivalent on 1989-09-05. Applicant: Pharmacia Eni Diagnostics, Inc.. Device class: 1.

Clearance details

Applicant: Pharmacia Eni Diagnostics, Inc.
Product code: Code JJQ
Device class: Class 1
Regulation: 21 CFR 862.2300
Advisory panel: Clinical Chemistry
Date received: 1989-07-19
Decision date: 1989-09-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Columbia, MD, US

Download summary PDF View on FDA.gov ↗

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