CMV CF ANTIGEN— 510(k) K853277

Substantially Equivalent

Hillcrest Biologicals

FDA 510(k) clearance K853277 for CMV CF ANTIGEN, Substantially Equivalent on 1985-11-07. Applicant: Hillcrest Biologicals. Device class: 2.

Clearance details

Applicant: Hillcrest Biologicals
Product code: Code GQI
Device class: Class 2
Regulation: 21 CFR 866.3175
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 ↗

Recent devices under product code GQI

K951800 — CMV IGG HUMAN SERUM CONTROLS1995-11-16
K952254 — ENZYME LINKED IMMUNOABSORBENT ASSAY, CYTOMEGALOVIRUS1995-11-16
K942171 — CMV EARLY ANTIGEN TEST1994-06-30
K883102 — VIRGO (R) CMV-IGG ELISA1989-02-08
K875159 — DETECTADOT SYSTEM 2000 CMV IGG TEST1988-05-06

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.