CMV TEST— 510(k) K853137

Substantially Equivalent

Gull Laboratories, Inc.

FDA 510(k) clearance K853137 for CMV TEST, Substantially Equivalent on 1985-11-14. Applicant: Gull Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Gull Laboratories, Inc.
Product code: Code GQI
Device class: Class 2
Regulation: 21 CFR 866.3175
Advisory panel: Microbiology
Date received: 1985-07-26
Decision date: 1985-11-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Salt Lake City, UT, US

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 Gull Laboratories, Inc.

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K935730 — EBNA IGG ELISA TEST1995-09-19
K940093 — EBV-EA(D) IGG ELISA TEST1995-09-15

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