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510(k) K843189

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

K843189 is an FDA 510(k) premarket notification submitted by Labsystems, Inc. for the device "CYTOMEGALOVIRUS IGG EIA TEST KIT". The FDA issued a decision of Substantially Equivalent on January 8, 1986. The device falls under product code GQI (Antiserum, Cf, Cytomegalovirus), a Class II device regulated under 21 CFR 866.3175. Labsystems, Inc. has at least 10 other 510(k) clearances on record.

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

  • 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)
  • 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)

FDA data resources