COXSACKIE A2 CF ANTIGEN, A4, A10 & A16— 510(k) K853279

Name: FDA 510(k) clearance K853279
Creator: U.S. Food and Drug Administration
Published: 1985-11-07

Substantially Equivalent

Hillcrest Biologicals

FDA 510(k) clearance K853279 for COXSACKIE A2 CF ANTIGEN, A4, A10 & A16, Substantially Equivalent on 1985-11-07. Applicant: Hillcrest Biologicals. Device class: 1.

Clearance details

Applicant: Hillcrest Biologicals
Product code: Code GNO
Device class: Class 1
Regulation: 21 CFR 866.3145
Advisory panel: Microbiology
Date received: 1985-08-05
Decision date: 1985-11-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cypress, CA, US

Download summary PDF View on FDA.gov ↗

More clearances from Hillcrest Biologicals

view all

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.