510(k) K942171

CMV EARLY ANTIGEN TEST by Neogenex — Product Code GQI

K942171 is an FDA 510(k) premarket notification submitted by Neogenex for the device "CMV EARLY ANTIGEN TEST". The FDA issued a decision of Substantially Equivalent on Jun 30, 1994. The device falls under product code GQI (Antiserum, Cf, Cytomegalovirus), a Class II device regulated under 21 CFR 866.3175. Neogenex has 19 other 510(k) clearances on record.

Clearance details

Decision: SESE (Substantially Equivalent)
Decision Date: Jun 30, 1994
Date Received: May 5, 1994
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device classification

Device Name: Antiserum, Cf, Cytomegalovirus
Device Class: Class II
Regulation Number: 866.3175
Review Panel: MI
Submission Type: 510(k)

Other clearances by Neogenex

K965047 — MINK LUNG CELL CULTURE (Feb 4, 1997)
K960909 — H292 CELL CULTURE (May 30, 1996)
K943884 — PRIMARY MONKEY KIDNEY CELL CULTURE (Nov 28, 1994)
K943888 — MDCK CELL CULTURE (Nov 28, 1994)
K943891 — RD CULTURE CELL (Nov 28, 1994)
K943889 — VERO CELL CULTURE (Nov 28, 1994)
K943887 — HUMAN NEWBORN FORESKIN CELL CULTURE (Nov 28, 1994)
K943886 — BGM CELL CULTURE (Nov 28, 1994)
K943885 — PRIMARY RABBIT KIDNEY CELL CULTURE (Nov 28, 1994)
K943890 — WI38 CELL CULTURE (Nov 28, 1994)

Other clearances for product code GQI

K952254 — ENZYME LINKED IMMUNOABSORBENT ASSAY, CYTOMEGALOVIRUS (Nov 16, 1995)
K951800 — CMV IGG HUMAN SERUM CONTROLS (Nov 16, 1995)
K883102 — VIRGO (R) CMV-IGG ELISA (Feb 8, 1989)
K875159 — DETECTADOT SYSTEM 2000 CMV IGG TEST (May 6, 1988)
K863488 — ENZYGNOST ANTI-CMV IGG TEST (Jul 20, 1987)
K864420 — CMV MICROASSAY (Feb 2, 1987)
K861123 — THE GOLDEN QUAD TEST (CMV) (Feb 2, 1987)
K862705 — CYTOMEGALOVIRUS IGG EIA TEST KIT (Oct 1, 1986)
K853989 — COR DOT CMV (Jun 13, 1986)
K860493 — CYTOTECH CMV IGG EIA (May 20, 1986)

510(k) K942171

Clearance details

Device classification

Other clearances by Neogenex

Other clearances for product code GQI

FDA data resources