Q FEVER IGM IFA TEST— 510(k) K922374

Substantially Equivalent

Hillcrest Biologicals

FDA 510(k) clearance K922374 for Q FEVER IGM IFA TEST, Substantially Equivalent on 1992-10-21. Applicant: Hillcrest Biologicals. Device class: 1.

Clearance details

Applicant: Hillcrest Biologicals
Product code: Code GPJ
Device class: Class 1
Regulation: 21 CFR 866.3500
Advisory panel: Microbiology
Date received: 1992-05-20
Decision date: 1992-10-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cypress, CA, US

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Recent devices under product code GPJ

K913906 — Q FEVER IGG IFA TEST1992-10-21

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K896594 — EBV VCA ANTIBODY (IGM)1990-01-16
K884829 — EBV EARLY ANTIGEN (R+D)1989-04-12

Data sourced from openFDA. This site is unofficial and independent of the FDA.