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510(k) K810043

GOAT ANTI-HERPES SIMPLEX VIRUS TYPE I by Vibac Corp. — Product Code GQM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 15, 1981
Date Received
January 7, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances for product code GQM

  • K875367 — COLORGENE FLUORESCENT DNA HYBRIDIZATION TEST / CMV (March 28, 1988)
  • K791397 — HERPES EIA TEST KIT (September 24, 1979)