THE GOLDEN QUAD TEST (CMV)— 510(k) K861123

Name: FDA 510(k) clearance K861123
Creator: U.S. Food and Drug Administration
Published: 1987-02-02

Substantially Equivalent

Microbiological Research Corp.

FDA 510(k) clearance K861123 for THE GOLDEN QUAD TEST (CMV), Substantially Equivalent on 1987-02-02. Applicant: Microbiological Research Corp.. Device class: 2.

Clearance details

Applicant: Microbiological Research Corp.
Product code: Code GQI
Device class: Class 2
Regulation: 21 CFR 866.3175
Advisory panel: Microbiology
Date received: 1986-03-25
Decision date: 1987-02-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bountiful, UT, US

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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 Microbiological Research Corp.

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K883011 — MRI NEO-TRYP TRYPSIN RIA1989-04-26
K861120 — THE GOLDEN QUAD TEST (HSV)1987-02-02
K861121 — THE GOLDEN QUAD TEST (EBV)1987-02-02
K861122 — THE GOLDEN QUAD TEST (TOXO)1987-02-02
K860450 — THE CMV-IGM TEST1986-05-13

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