PHASE II FSH KIT— 510(k) K883279

Substantially Equivalent

Vitek Systems, Inc.

FDA 510(k) clearance K883279 for PHASE II FSH KIT, Substantially Equivalent on 1988-09-09. Applicant: Vitek Systems, Inc.. Device class: 1.

Clearance details

Applicant: Vitek Systems, Inc.
Product code: Code CGJ
Device class: Class 1
Regulation: 21 CFR 862.1300
Advisory panel: Clinical Chemistry
Date received: 1988-08-03
Decision date: 1988-09-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rockland, MA, US

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