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510(k) K904095

HERPES SIMPLEX VIRUS TISSUE CULTURE CONF. TYPING by California Integrated Diagnostics, Inc. — Product Code GQL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 1, 1991
Date Received
September 6, 1990
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

Other clearances by California Integrated Diagnostics, Inc.

  • K874259 — TRICHOMONAS DIRECT ENZYME IMMUNOASSAY (December 7, 1987)
  • K871278 — MODIFIED CHLAMYDIA DIRECT SPECIMEN TEST KIT (April 8, 1987)
  • K871279 — MODIFIED TRICHOMONAS DIRECT SPECIMEN TEST KIT (April 8, 1987)

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  • K984135 — THE APTUS (AUTOMATED) APPLICATION OF THE HSV-1 IGG ELISA TEST SYSTEM. AN ENZYME (May 26, 1999)
  • K905608 — INDIRECT FLUORESCENT ASSAY FOR HERPES SIMPLEX 1 (November 7, 1991)
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  • K891162 — HSV-1 ELISA TEST SYSTEM (June 20, 1989)
  • K891782 — HSV-2 ELISA TEST SYSTEM (June 20, 1989)