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510(k) K841943

GIBCO HERPES ID KIT by Gibco Laboratories Life Technologies, Inc. — Product Code GQL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 13, 1985
Date Received
May 11, 1984
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 Gibco Laboratories Life Technologies, Inc.

  • K871855 — SORBITOL MACCONKEY (SMAC) AGAR, DRI & PRE-FORM (May 26, 1987)
  • K871541 — MARTIN-LEWIS AGAR W/REDUCED VANCOMYCIN C0226 (April 29, 1987)
  • K870134 — MCBRIDE LISTERIA AGAR W/CYCLOHEXIMIDE, DRI & PRE (February 4, 1987)
  • K864755 — PSEUDOMONAS CEPACIA SELECTIVE AGAR, DRI & PRE-FORM (January 5, 1987)
  • K864014 — LOMBARD DOWELL AGAR BASE (October 29, 1986)
  • K863821 — MUELLER HINTON AGAR W/4%NACL AND OXACILLIN (October 9, 1986)
  • K863820 — DRI-FORM: GBNA LISTERIA MEDIUM NO. M22300 (October 8, 1986)
  • K863289 — CDC ANAEROBIC AGAR W/SHEEP BLOOD, KANA-&VANCOMYCIN (September 3, 1986)
  • K862425 — MACCONKEY AGAR W/MUG, DRI-FORM AND PRE-FORM (July 2, 1986)
  • K861058 — SENSITITRE AUTO ID PLATE, AP70 (May 20, 1986)

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  • K984135 — THE APTUS (AUTOMATED) APPLICATION OF THE HSV-1 IGG ELISA TEST SYSTEM. AN ENZYME (May 26, 1999)
  • 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)