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510(k) K984135

THE APTUS (AUTOMATED) APPLICATION OF THE HSV-1 IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR by Zeus Scientific, Inc. — Product Code GQL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 26, 1999
Date Received
November 18, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antisera, Fluorescent, Herpesvirus Hominis 1,2
Device Class
Class II
Regulation Number
866.3305
Review Panel
MI
Submission Type

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Other clearances for product code GQL

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  • K984120 — THE APTUS(AUTOMATED) APPLICATION OF THE HSV-2 IGG ELISA TEST SYSTEM. AN ENZYME L (May 26, 1999)
  • K905608 — INDIRECT FLUORESCENT ASSAY FOR HERPES SIMPLEX 1 (November 7, 1991)
  • K904095 — HERPES SIMPLEX VIRUS TISSUE CULTURE CONF. TYPING (February 1, 1991)
  • K904167 — PATHODX HERPES TYPING (December 13, 1990)
  • K902661 — BARTELS HERPES SIMPLEX VIR FLU MONO ANTIB HSV-1&2 (July 31, 1990)
  • K902662 — BARTELS HERPES SIMPLEX VIR FLU MONO ANTIBODY TEST (July 31, 1990)
  • K891162 — HSV-1 ELISA TEST SYSTEM (June 20, 1989)
  • K891782 — HSV-2 ELISA TEST SYSTEM (June 20, 1989)