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510(k) K822734

EBV IGM TEST by Gull Laboratories, Inc. — Product Code JRY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 9, 1982
Date Received
September 9, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antiserum, Fluorescent, Epstein-Barr Virus
Device Class
Class I
Regulation Number
866.3235
Review Panel
MI
Submission Type

Other clearances by Gull Laboratories, Inc.

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  • K971857 — MUMPS IGG ELISA TESTY (November 4, 1997)
  • K962343 — TOXO IGG ELISA TEST (March 24, 1997)
  • K935730 — EBNA IGG ELISA TEST (September 19, 1995)
  • K940093 — EBV-EA(D) IGG ELISA TEST (September 15, 1995)
  • K941046 — VZV IGG ELISA TEST (August 24, 1995)
  • K941198 — EBV LGG ELISA TEST (August 23, 1995)
  • K932333 — PROTECTORAL ULTRASONIC HANDPIECE PROCESSOR (August 15, 1995)
  • K941624 — RUBELLA IGG ELISA TEST (August 4, 1995)
  • K922758 — HSV-1 IGM ELISA TEST -- MODIFICATION (October 5, 1992)

Other clearances for product code JRY

  • K042118 — ATHENA MULTI-LYTE EBV IGG TEST SYSTEM (April 29, 2005)
  • K900974 — INDIRECT FLUORESCENT ASSAY FOR (EBV-VCA) IGG ANTI. (April 16, 1990)
  • K891785 — BION EBV-G (VCA) TEST SYSTEM (August 31, 1989)
  • K884829 — EBV EARLY ANTIGEN (R+D) (April 12, 1989)
  • K822985 — EBV-M KIT (December 3, 1982)
  • K821849 — EBV-VCA ANTIBODY ASSAY KIT (August 12, 1982)
  • K811262 — EPSTEIN-BARR VIRUS CAPSID ANTIGEN ANTI (May 27, 1981)
  • K780925 — EB-VCA, TEST, ANTIBODY, FLUORESCENT (June 22, 1978)