RIA SYS. FOR HUMAN LUTEINIZING HORMONE— 510(k) K780367

Name: FDA 510(k) clearance K780367
Creator: U.S. Food and Drug Administration
Published: 1978-04-28

Substantially Equivalent

Calbiochem-Behring Corp.

FDA 510(k) clearance K780367 for RIA SYS. FOR HUMAN LUTEINIZING HORMONE, Substantially Equivalent on 1978-04-28. Applicant: Calbiochem-Behring Corp.. Device class: 1.

Clearance details

Applicant: Calbiochem-Behring Corp.
Product code: Code CEP
Device class: Class 1
Regulation: 21 CFR 862.1485
Advisory panel: Clinical Chemistry
Date received: 1978-03-07
Decision date: 1978-04-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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