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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 June 30, 1994. The device falls under product code GQI (Antiserum, Cf, Cytomegalovirus), a Class II device regulated under 21 CFR 866.3175. Neogenex has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 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

Other clearances by Neogenex

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

Other clearances for product code GQI

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

FDA data resources