CMV MICROASSAY— 510(k) K864420

Substantially Equivalent

Diamedix Corp.

FDA 510(k) clearance K864420 for CMV MICROASSAY, Substantially Equivalent on 1987-02-02. Applicant: Diamedix Corp.. Device class: 2.

Clearance details

Applicant: Diamedix Corp.
Product code: Code GQI
Device class: Class 2
Regulation: 21 CFR 866.3175
Advisory panel: Microbiology
Date received: 1986-11-10
Decision date: 1987-02-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami, FL, 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

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K013628 — DIAMEDIX IS-ANTI-B2 GLYCOPROTEIN I IGG/IGM TEST SYSTEM2001-12-21
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Data sourced from openFDA. This site is unofficial and independent of the FDA.