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510(k) K883601

EPSTEIN-BARR VIRUS (EBNA-1) IGM CATA. #5550 by Clinical Sciences, Inc. — Product Code LLM

K883601 is an FDA 510(k) premarket notification submitted by Clinical Sciences, Inc. for the device "EPSTEIN-BARR VIRUS (EBNA-1) IGM CATA. #5550". The FDA issued a decision of Substantially Equivalent on May 11, 1989. The device falls under product code LLM (Test, Antigen, Nuclear, Epstein-Barr Virus), a Class I device regulated under 21 CFR 866.3235. Clinical Sciences, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 11, 1989
Date Received
August 23, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Test, Antigen, Nuclear, Epstein-Barr Virus
Device Class
Class I
Regulation Number
866.3235
Review Panel
MI
Submission Type

Other clearances by Clinical Sciences, Inc.

  • K900688 — VARICELLA ZOSTER IGG CLIN-ELISA TEST KIT (May 15, 1990)
  • K883871 — EPSTEIN-BARR VIRAL CAPSID ANTIGEN IGM #5590 (July 14, 1989)
  • K883870 — EPSTEIN-BARR VIRAL CAPSID ANTIGEN IGG #4590 (July 14, 1989)
  • K891990 — RUBEOLA IGG CLIN-ELISA TEST SYSTEM, CAT. #4600 (June 15, 1989)
  • K883600 — EPSTEIN-BARR VIRUS (EBNA-1) IGG CATA. #4550 (May 11, 1989)
  • K874594 — TOXOPLASMA IGM CLIN-ELISA(TM) CAT # 5560 (March 7, 1988)
  • K872942 — IGM CMV CLIN-ELISA(TM) TEST SYSTEM NUMBER: 5530 (January 11, 1988)
  • K860145 — RUBELLA ELISA TEST SYSTEM CATALOG NUMBER: 4540 (July 14, 1986)
  • K860773 — TOXOPLASMA IGG CLIN-ELISA TEST KIT CAT. NO. 4560 (May 23, 1986)
  • K854666 — CYTOMEGALOVIRUS (CMV) ELISA TEST SYS. CAT. NO:4530 (February 5, 1986)

Other clearances for product code LLM

  • K233605 — ADVIA Centaur EBV-EBNA IgG (August 7, 2024)
  • K040120 — DIASORIN LIAISON EBNA IGG, LIAISON VCA IGG, LIAISON VCA IGM ASSAYS (April 29, 2005)
  • K984133 — THE APTUS (AUTOMATED) APPLICATION OF THE EBNA IGG ELISA TEST SYSTEM. AN ENZYME L (January 11, 1999)
  • K973941 — IMMUNOWELL EBNA IGG TEST (August 10, 1998)
  • K980598 — EBNA-1 IGM ELISA TEST SYSTEM (May 1, 1998)
  • K951549 — EBNA IGG EIA TEST SYSTEM (April 29, 1996)
  • K951822 — EBNA ENZYME IMMUNOASSAY KIT (February 15, 1996)
  • K935730 — EBNA IGG ELISA TEST (September 19, 1995)
  • K946353 — EPSTEIN-BARR VIRUS NUCLEAR ANTIGEN RECOMBINANT IMMUNOFLUORESCENT ASSAY (July 21, 1995)
  • K946158 — INCSTAR EPSTEIN-BARR NUCLEAR ANTIGEN (EBNA_ IGG ELISA KIT (June 9, 1995)

FDA data resources