Home / 510(k) Clearances / K880883

510(k) K880883

EBV-VCA IGG ANTIBODY TEST SYSTEM (FLUORESCENT) by Immuno Concepts, Inc. — Product Code GNP

K880883 is an FDA 510(k) premarket notification submitted by Immuno Concepts, Inc. for the device "EBV-VCA IGG ANTIBODY TEST SYSTEM (FLUORESCENT)". The FDA issued a decision of Substantially Equivalent on August 30, 1988. The device falls under product code GNP (Antiserum, Cf, Epstein-Barr Virus), a Class I device regulated under 21 CFR 866.3235. Immuno Concepts, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 30, 1988
Date Received
March 2, 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 Immuno Concepts, Inc.

  • K013432 — IGG ANTI-NDNA FLUORESCENT TEST SYSTEM; MODEL # 3040G (November 29, 2001)
  • K013285 — RELISA MPO-ANCA TEST SYSTEM FOR ANTIBODIES TO MYELOPEROXIDASE, MODEL # 7096-15 (November 14, 2001)
  • K013283 — RELISA PR3-ANCA TEST SYSTEM FOR ANTIBODIES TO PROTEINASE 3, MODEL # 7096-16 (November 14, 2001)
  • K992041 — RELISA ANA SCREENING TEST SYSTEM, MODEL 7096-11 (July 23, 1999)
  • K983924 — HEP-2000 COLORZYME ANA-RO TEST SYSTEM, MODEL 4200-RO (December 18, 1998)
  • K972145 — HEP-2000 FLUORESCENT ANA-RO TEST SYSTEM (February 24, 1998)
  • K974478 — IMMUNO CONCEPTS ANCA TEST SYSTEMS (February 9, 1998)
  • K974463 — IMMUNO CONCEPTS ANCA TEST SYSTEM (February 9, 1998)
  • K963275 — RELISA ENA SINGLE WELL SCREEN ANTIBODY TEST SYSTEM (September 13, 1996)
  • K955603 — RELSIA SS-A/RO & SS/B LA ANTIBODY TEST SYSTEM (April 19, 1996)

Other clearances for product code GNP

  • K020717 — EBV V VCA IGM ELISA KIT MODEL# EBM-200 (June 13, 2002)
  • K020706 — EBV-VCA IGG ELISA TEST, MODEL EBG-100 (June 13, 2002)
  • K020707 — EBV-EBNA IGG ELISA KIT, 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)
  • 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)
  • K871373 — EBV-CHECK(TM) TEST KIT (IGG) (June 25, 1987)

FDA data resources