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510(k) K780006

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

K780006 is an FDA 510(k) premarket notification submitted by Northeast Biomedical Labs., Inc. for the device "GOAT ANTI-INFLUENZA ANTISERA". The FDA issued a decision of Substantially Equivalent on January 20, 1978. The device falls under product code GNS (Antisera, Hai, Influenza Virus A, B, C), a Class I device regulated under 21 CFR 866.3330. Northeast Biomedical Labs., Inc. has at least 8 other 510(k) clearances on record.

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, Hai, Influenza Virus A, B, C
Device Class
Class I
Regulation Number
866.3330
Review Panel
MI
Submission Type

Other clearances by Northeast Biomedical Labs., Inc.

  • K780697 — GOAT ANTI-INFLUENZA ANTISERA ATEXAS (May 3, 1978)
  • K780696 — GOAT ANTIINFLUENZA ANTISERA AUSSR (May 3, 1978)
  • K780010 — GOAT ANTI-RUBELLA ANTISERA (January 20, 1978)
  • K780007 — GOAT ANTI-INFLUENZA ANTISERA (January 20, 1978)
  • K780009 — GUINEA PIG WHOLE SERUM (January 20, 1978)
  • K780004 — GOAT ANTI-INFLUENZA ANTISERA (January 20, 1978)
  • K780008 — GOAT ANTI-INFLUENZA ANTISERA (January 20, 1978)
  • K780005 — GOAT ANTI-INFLUENZA ANTISERA (January 20, 1978)

Other clearances for product code GNS

  • K780697 — GOAT ANTI-INFLUENZA ANTISERA ATEXAS (May 3, 1978)
  • K780696 — GOAT ANTIINFLUENZA ANTISERA AUSSR (May 3, 1978)
  • K780273 — INFLUENZA HI PRESERUM (February 28, 1978)
  • K780276 — INFLUENZA HI ANTISERUM A/TEXAS (February 28, 1978)
  • K780274 — INFLUENZA HI ANTISERUM (February 28, 1978)
  • K780277 — INFLUENZA HI PRESERUM A/TEXAS (February 28, 1978)
  • K780005 — GOAT ANTI-INFLUENZA ANTISERA (January 20, 1978)
  • K780004 — GOAT ANTI-INFLUENZA ANTISERA (January 20, 1978)

FDA data resources