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510(k) K883670

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

K883670 is an FDA 510(k) premarket notification submitted by Electro-Nucleonics, Inc. for the device "SEROLOGICAL TEST KIT FOR IGG ANTI. EPSTEIN-BARR VI". The FDA issued a decision of Substantially Equivalent on April 28, 1989. The device falls under product code GNP (Antiserum, Cf, Epstein-Barr Virus), a Class I device regulated under 21 CFR 866.3235. Electro-Nucleonics, Inc. has at least 8 other 510(k) clearances on record.

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.

  • K893718 — DELTATEST (R) LIPASE II (September 28, 1989)
  • K883281 — VIRGO HSV-2 IGG ELISA (March 10, 1989)
  • K883282 — VIRGO HSV-1 IGG ELISA (March 10, 1989)
  • K883427 — VIRGO(R) VZV-IGG ELISA (March 10, 1989)
  • K883102 — VIRGO (R) CMV-IGG ELISA (February 8, 1989)
  • K884784 — VIRGO(R) MICROWELL ALT ASSAY (December 29, 1988)
  • K883205 — ALTLTS ALANINE AMINO TRANSFERASE ALT (September 9, 1988)
  • K883206 — LACTATE DEHYDROGENASE LDH (September 9, 1988)

Other clearances for product code GNP

  • K020717 — EBV V VCA IGM ELISA KIT MODEL# EBM-200 (June 13, 2002)
  • K020707 — EBV-EBNA IGG ELISA KIT, MODEL EBG-100 (June 13, 2002)
  • K020706 — EBV-VCA IGG ELISA TEST, MODEL EBG-100 (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)
  • 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)

FDA data resources