Home / 510(k) Clearances / K984133

510(k) K984133

THE APTUS (AUTOMATED) APPLICATION OF THE EBNA IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR TH by Zeus Scientific, Inc. — Product Code LLM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 11, 1999
Date Received
November 18, 1998
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

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Other clearances for product code LLM

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  • 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)
  • K932742 — EBNA IGG ELISA TEST SYSTEM (May 5, 1995)