EBV VCA ANTIBODY (IGM)— 510(k) K896594

Substantially Equivalent

Hillcrest Biologicals

FDA 510(k) clearance K896594 for EBV VCA ANTIBODY (IGM), Substantially Equivalent on 1990-01-16. Applicant: Hillcrest Biologicals. Device class: 1.

Clearance details

Applicant: Hillcrest Biologicals
Product code: Code LJN
Device class: Class 1
Regulation: 21 CFR 866.3235
Advisory panel: Microbiology
Date received: 1989-11-21
Decision date: 1990-01-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cypress, CA, US

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More clearances from Hillcrest Biologicals

K913617 — ARBOVIRUS IGG IFA TEST1992-12-03
K913618 — ARBOVIRUS IGM IFA TEST1992-12-03
K913906 — Q FEVER IGG IFA TEST1992-10-21
K922374 — Q FEVER IGM IFA TEST1992-10-21
K900206 — LYME DISEASE IGM ELISA1991-06-28

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