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510(k) K780008

GOAT ANTI-INFLUENZA ANTISERA by Northeast Biomedical Labs., Inc. — Product Code GQT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 20, 1978
Date Received
January 3, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antisera, Cf, Parainfluenza Virus 1-4
Device Class
Class I
Regulation Number
866.3400
Review Panel
MI
Submission Type

Other clearances by Northeast Biomedical Labs., Inc.

  • K780696 — GOAT ANTIINFLUENZA ANTISERA AUSSR (May 3, 1978)
  • K780697 — GOAT ANTI-INFLUENZA ANTISERA ATEXAS (May 3, 1978)
  • K780006 — GOAT ANTI-INFLUENZA ANTISERA (January 20, 1978)
  • K780004 — GOAT ANTI-INFLUENZA ANTISERA (January 20, 1978)
  • K780010 — GOAT ANTI-RUBELLA ANTISERA (January 20, 1978)
  • K780005 — GOAT ANTI-INFLUENZA ANTISERA (January 20, 1978)
  • K780009 — GUINEA PIG WHOLE SERUM (January 20, 1978)
  • K780007 — GOAT ANTI-INFLUENZA ANTISERA (January 20, 1978)

Other clearances for product code GQT

  • K872695 — PARAINFLUENZA-2-CF ANTIGEN AND CONTROL ANTIGEN (September 18, 1987)
  • K872696 — PARAINFLUENZA-3-CF ANTIGEN AND CONTROL ANTIGEN (September 18, 1987)
  • K872697 — PARAINFLUENZA-I-CF ANTIGEN AND CONTROL ANTIGEN (September 18, 1987)