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510(k) K871373

EBV-CHECK(TM) TEST KIT (IGG) by Diagnostic Technology, Inc. — Product Code GNP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 25, 1987
Date Received
April 7, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Diagnostic Technology, Inc.

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  • K890639 — RESUBMITTED EBV/IGM-CHECK TEST KIT (June 20, 1989)
  • K890819 — HSV-CHECK(TM) TEST KIT (June 20, 1989)
  • K864128 — CHLAMYDIA-CHECK(TM) DIRECT & CULTURE CONFIR. KIT (April 29, 1987)
  • K863408 — EBV/VCA-CHECK(TM) ANTIGEN SLIDES (November 28, 1986)
  • K860586 — PHA-2 CONVERSION PROGRAM FOR PLATELET ANALYSIS (May 7, 1986)
  • K860166 — PICOSCALE BLOOD CELL COUNTER, MODEL PS-5 (April 4, 1986)
  • K853036 — PICOSCALE LABORSCALE, #PSL-1 & ANALYSER, #PSA-1 (November 5, 1985)

Other clearances for product code GNP

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  • K020717 — EBV V VCA IGM ELISA KIT MODEL# EBM-200 (June 13, 2002)
  • K981831 — IS EBV-EA-D IGG ELISA TEST SYSTEM (February 16, 1999)
  • K981829 — IS EBV-EBNA-1 IGG ELISA TEST SYSTEM (February 16, 1999)
  • K901156 — EIA FOR IGG ANTIBODY TO EBV VCA IN HUMAN SERUM (September 12, 1990)
  • K883670 — SEROLOGICAL TEST KIT FOR IGG ANTI. EPSTEIN-BARR VI (April 28, 1989)
  • K884591 — EBV-VCA ANTIBODY (IGG) (January 24, 1989)
  • K880885 — EBV-VCA IGG ANTIBODY TEST SYSTEM (ENZYME) (August 30, 1988)
  • K880883 — EBV-VCA IGG ANTIBODY TEST SYSTEM (FLUORESCENT) (August 30, 1988)