HERPES HOMINUS I-COMPLE FIX ANTIGEN & NEGATIVE CLT— 510(k) K852931

Name: FDA 510(k) clearance K852931
Creator: U.S. Food and Drug Administration
Published: 1985-11-12

Substantially Equivalent

Microbix Biosystems, Inc.

FDA 510(k) clearance K852931 for HERPES HOMINUS I-COMPLE FIX ANTIGEN & NEGATIVE CLT, Substantially Equivalent on 1985-11-12. Applicant: Microbix Biosystems, Inc.. Device class: 2.

Clearance details

Applicant: Microbix Biosystems, Inc.
Product code: Code GQO
Device class: Class 2
Regulation: 21 CFR 866.3305
Advisory panel: Microbiology
Date received: 1985-07-09
Decision date: 1985-11-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Canada, CA

Download summary PDF View on FDA.gov ↗

Recent devices under product code GQO

view all

K883281 — VIRGO HSV-2 IGG ELISA1989-03-10
K883282 — VIRGO HSV-1 IGG ELISA1989-03-10
K881261 — BION HSV1-G OR HSV2-G TEST SYSTEM1988-06-07
K875366 — THE DDI SERODOT HERPES IGG TEST KIT1988-05-23
K871426 — VIROGEN HSV ANTIBODY TEST1987-10-15

More clearances from Microbix Biosystems, Inc.

view all

K894261 — TOXOPLASMA GONDII-CF ANTIGEN AND CONTROL ANTIGEN1989-10-16
K894262 — RUBELLA ANTIGEN AND CONTROL ANTIGEN1989-10-16
K852929 — CMV-COMPLEMENT FIXATION ANTIGEN AND NEGATIVE CONTR1985-11-12
K852930 — VARICELLA-ZOSTER-COMPLE FIX ANTIGEN AND NEG CONTRO1985-11-12
K852932 — MEASLES-COMPLEMENT FIX ANTIGEN & NEGATIVE CLT1985-11-12

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