CMV-COMPLEMENT FIXATION ANTIGEN AND NEGATIVE CONTR— 510(k) K852929

Name: FDA 510(k) clearance K852929
Creator: U.S. Food and Drug Administration
Published: 1985-11-12

Substantially Equivalent

Microbix Biosystems, Inc.

FDA 510(k) clearance K852929 for CMV-COMPLEMENT FIXATION ANTIGEN AND NEGATIVE CONTR, Substantially Equivalent on 1985-11-12. Applicant: Microbix Biosystems, Inc.. Device class: 2.

Clearance details

Applicant: Microbix Biosystems, Inc.
Product code: Code GQI
Device class: Class 2
Regulation: 21 CFR 866.3175
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 GQI

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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 Microbix Biosystems, Inc.

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K894261 — TOXOPLASMA GONDII-CF ANTIGEN AND CONTROL ANTIGEN1989-10-16
K894262 — RUBELLA ANTIGEN AND CONTROL ANTIGEN1989-10-16
K852930 — VARICELLA-ZOSTER-COMPLE FIX ANTIGEN AND NEG CONTRO1985-11-12
K852931 — HERPES HOMINUS I-COMPLE FIX ANTIGEN & NEGATIVE CLT1985-11-12
K852932 — MEASLES-COMPLEMENT FIX ANTIGEN & NEGATIVE CLT1985-11-12

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