RICKETTSIAL IGG AND IGM IFA KIT— 510(k) K864110

Name: FDA 510(k) clearance K864110
Creator: U.S. Food and Drug Administration
Published: 1987-03-12

Substantially Equivalent

Hillcrest Biologicals

FDA 510(k) clearance K864110 for RICKETTSIAL IGG AND IGM IFA KIT, Substantially Equivalent on 1987-03-12. Applicant: Hillcrest Biologicals. Device class: 1.

Clearance details

Applicant: Hillcrest Biologicals
Product code: Code GPN
Device class: Class 1
Regulation: 21 CFR 866.3500
Advisory panel: Microbiology
Date received: 1986-10-21
Decision date: 1987-03-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cypress, CA, US

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