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510(k) K883670

SEROLOGICAL TEST KIT FOR IGG ANTI. EPSTEIN-BARR VI by Electro-Nucleonics, Inc. — Product Code GNP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 28, 1989
Date Received
August 18, 1988
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 Electro-Nucleonics, Inc.

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  • K883281 — VIRGO HSV-2 IGG ELISA (March 10, 1989)
  • K883102 — VIRGO (R) CMV-IGG ELISA (February 8, 1989)
  • K884784 — VIRGO(R) MICROWELL ALT ASSAY (December 29, 1988)
  • K883206 — LACTATE DEHYDROGENASE LDH (September 9, 1988)
  • K883205 — ALTLTS ALANINE AMINO TRANSFERASE ALT (September 9, 1988)

Other clearances for product code GNP

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  • 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)
  • K884591 — EBV-VCA ANTIBODY (IGG) (January 24, 1989)
  • K880883 — EBV-VCA IGG ANTIBODY TEST SYSTEM (FLUORESCENT) (August 30, 1988)
  • K880885 — EBV-VCA IGG ANTIBODY TEST SYSTEM (ENZYME) (August 30, 1988)
  • K871373 — EBV-CHECK(TM) TEST KIT (IGG) (June 25, 1987)