FOLATE RADIOASSAY KIT— 510(k) K801198

Substantially Equivalent

Calbiochem-Behring Corp.

FDA 510(k) clearance K801198 for FOLATE RADIOASSAY KIT, Substantially Equivalent on 1980-07-21. Applicant: Calbiochem-Behring Corp.. Device class: 2.

Clearance details

Applicant: Calbiochem-Behring Corp.
Product code: Code CGN
Device class: Class 2
Regulation: 21 CFR 862.1295
Advisory panel: Clinical Chemistry
Date received: 1980-05-19
Decision date: 1980-07-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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