RIAGEN PAP RIA— 510(k) K813261

Substantially Equivalent

Biogenex Laboratories

FDA 510(k) clearance K813261 for RIAGEN PAP RIA, Substantially Equivalent on 1981-12-17. Applicant: Biogenex Laboratories. Device class: 2.

Clearance details

Applicant: Biogenex Laboratories
Product code: Product code JFH
Device class: Class 2
Regulation: 21 CFR 862.1020
Advisory panel: Clinical Chemistry
Date received: 1981-11-20
Decision date: 1981-12-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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