MODIFIED OVUGEN— 510(k) K902208

Substantially Equivalent

Biogenex Laboratories

FDA 510(k) clearance K902208 for MODIFIED OVUGEN, Substantially Equivalent on 1990-07-17. Applicant: Biogenex Laboratories. Device class: 1.

Clearance details

Applicant: Biogenex Laboratories
Product code: Code CEP
Device class: Class 1
Regulation: 21 CFR 862.1485
Advisory panel: Clinical Chemistry
Date received: 1990-05-16
Decision date: 1990-07-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Ramon, CA, US

Download summary PDF View on FDA.gov ↗

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