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510(k) K780697

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

K780697 is an FDA 510(k) premarket notification submitted by Northeast Biomedical Labs., Inc. for the device "GOAT ANTI-INFLUENZA ANTISERA ATEXAS". The FDA issued a decision of Substantially Equivalent on May 3, 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
May 3, 1978
Date Received
April 24, 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.

  • K780696 — GOAT ANTIINFLUENZA ANTISERA AUSSR (May 3, 1978)
  • K780006 — GOAT ANTI-INFLUENZA ANTISERA (January 20, 1978)
  • K780005 — GOAT ANTI-INFLUENZA ANTISERA (January 20, 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)

Other clearances for product code GNS

  • K780696 — GOAT ANTIINFLUENZA ANTISERA AUSSR (May 3, 1978)
  • K780276 — INFLUENZA HI ANTISERUM A/TEXAS (February 28, 1978)
  • K780274 — INFLUENZA HI ANTISERUM (February 28, 1978)
  • K780273 — INFLUENZA HI PRESERUM (February 28, 1978)
  • K780277 — INFLUENZA HI PRESERUM A/TEXAS (February 28, 1978)
  • K780005 — GOAT ANTI-INFLUENZA ANTISERA (January 20, 1978)
  • K780006 — GOAT ANTI-INFLUENZA ANTISERA (January 20, 1978)
  • K780004 — GOAT ANTI-INFLUENZA ANTISERA (January 20, 1978)

FDA data resources