EBV EARLY ANTIGEN (R+D)— 510(k) K884829

Substantially Equivalent

Hillcrest Biologicals

FDA 510(k) clearance K884829 for EBV EARLY ANTIGEN (R+D), Substantially Equivalent on 1989-04-12. Applicant: Hillcrest Biologicals. Device class: 1.

Clearance details

Applicant: Hillcrest Biologicals
Product code: Code JRY
Device class: Class 1
Regulation: 21 CFR 866.3235
Advisory panel: Microbiology
Date received: 1988-11-18
Decision date: 1989-04-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cypress, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JRY

K042118 — ATHENA MULTI-LYTE EBV IGG TEST SYSTEM2005-04-29
K900974 — INDIRECT FLUORESCENT ASSAY FOR (EBV-VCA) IGG ANTI.1990-04-16
K891785 — BION EBV-G (VCA) TEST SYSTEM1989-08-31
K822734 — EBV IGM TEST1982-12-09
K822985 — EBV-M KIT1982-12-03

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.