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510(k) K883102

VIRGO (R) CMV-IGG ELISA by Electro-Nucleonics, Inc. — Product Code GQI

K883102 is an FDA 510(k) premarket notification submitted by Electro-Nucleonics, Inc. for the device "VIRGO (R) CMV-IGG ELISA". The FDA issued a decision of Substantially Equivalent on February 8, 1989. The device falls under product code GQI (Antiserum, Cf, Cytomegalovirus), a Class II device regulated under 21 CFR 866.3175. Electro-Nucleonics, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 8, 1989
Date Received
July 22, 1988
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 Electro-Nucleonics, Inc.

  • K893718 — DELTATEST (R) LIPASE II (September 28, 1989)
  • K883670 — SEROLOGICAL TEST KIT FOR IGG ANTI. EPSTEIN-BARR VI (April 28, 1989)
  • K883427 — VIRGO(R) VZV-IGG ELISA (March 10, 1989)
  • K883281 — VIRGO HSV-2 IGG ELISA (March 10, 1989)
  • K883282 — VIRGO HSV-1 IGG ELISA (March 10, 1989)
  • K884784 — VIRGO(R) MICROWELL ALT ASSAY (December 29, 1988)
  • K883206 — LACTATE DEHYDROGENASE LDH (September 9, 1988)
  • K883205 — ALTLTS ALANINE AMINO TRANSFERASE ALT (September 9, 1988)

Other clearances for product code GQI

  • K952254 — ENZYME LINKED IMMUNOABSORBENT ASSAY, CYTOMEGALOVIRUS (November 16, 1995)
  • K951800 — CMV IGG HUMAN SERUM CONTROLS (November 16, 1995)
  • K942171 — CMV EARLY ANTIGEN TEST (June 30, 1994)
  • 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