PHENCYCLIDINE DIRECT BLOOD RIA KIT— 510(k) K800514

Name: FDA 510(k) clearance K800514
Creator: U.S. Food and Drug Administration
Published: 1980-03-19

Substantially Equivalent

Immunalysis Corporation

FDA 510(k) clearance K800514 for PHENCYCLIDINE DIRECT BLOOD RIA KIT, Substantially Equivalent on 1980-03-19. Applicant: Immunalysis Corporation. Device class: Unclassified.

Clearance details

Applicant: Immunalysis Corporation
Product code: Code LCL
Device class: Unclassified
Advisory panel: Unknown
Date received: 1980-03-05
Decision date: 1980-03-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

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