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510(k) K854666

CYTOMEGALOVIRUS (CMV) ELISA TEST SYS. CAT. NO:4530 by Clinical Sciences, Inc. — Product Code GQI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 5, 1986
Date Received
November 21, 1985
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 Clinical Sciences, Inc.

  • K900688 — VARICELLA ZOSTER IGG CLIN-ELISA TEST KIT (May 15, 1990)
  • K883871 — EPSTEIN-BARR VIRAL CAPSID ANTIGEN IGM #5590 (July 14, 1989)
  • K883870 — EPSTEIN-BARR VIRAL CAPSID ANTIGEN IGG #4590 (July 14, 1989)
  • K891990 — RUBEOLA IGG CLIN-ELISA TEST SYSTEM, CAT. #4600 (June 15, 1989)
  • K883600 — EPSTEIN-BARR VIRUS (EBNA-1) IGG CATA. #4550 (May 11, 1989)
  • K883601 — EPSTEIN-BARR VIRUS (EBNA-1) IGM CATA. #5550 (May 11, 1989)
  • K874594 — TOXOPLASMA IGM CLIN-ELISA(TM) CAT # 5560 (March 7, 1988)
  • K872942 — IGM CMV CLIN-ELISA(TM) TEST SYSTEM NUMBER: 5530 (January 11, 1988)
  • K860145 — RUBELLA ELISA TEST SYSTEM CATALOG NUMBER: 4540 (July 14, 1986)
  • K860773 — TOXOPLASMA IGG CLIN-ELISA TEST KIT CAT. NO. 4560 (May 23, 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)
  • K864420 — CMV MICROASSAY (February 2, 1987)
  • K861123 — THE GOLDEN QUAD TEST (CMV) (February 2, 1987)
  • K862705 — CYTOMEGALOVIRUS IGG EIA TEST KIT (October 1, 1986)
  • K853989 — COR DOT CMV (June 13, 1986)