Home / 510(k) Clearances / K843189

510(k) K843189

CYTOMEGALOVIRUS IGG EIA TEST KIT by Labsystems, Inc. — Product Code GQI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 8, 1986
Date Received
August 13, 1984
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 Labsystems, Inc.

  • K923365 — TILT/REDUCED SHEAR SEMI-RECLINE SEATING SYSTEM (March 24, 1993)
  • K896474 — RESUBMITTED FECATWIN SENSITIVE - FECA-EIA (January 25, 1990)
  • K890154 — MODIFIED LABYSYSTEMS' TOXOPLASMA GONDII IGG EIA (February 7, 1989)
  • K890091 — MODIFIED LABSYSTEMS' RUBELLA IGG EIA TEST KIT (February 3, 1989)
  • K881243 — RUBELLA IGG - EIA TEST KIT NUMBER 61 07 201 (April 4, 1988)
  • K873780 — MODIFICATION RUBELLA IGM EIA TEST KIT (October 15, 1987)
  • K873583 — AUTO-EIA (September 22, 1987)
  • K872252 — MODIFIED TOXOPLASMA GONDII IGG EIA TEST KIT (July 1, 1987)
  • K862705 — CYTOMEGALOVIRUS IGG EIA TEST KIT (October 1, 1986)
  • K862431 — RUBELLA IGM EIA TEST KIT (August 8, 1986)

Other clearances for product code GQI

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