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510(k) K780009

GUINEA PIG WHOLE SERUM by Northeast Biomedical Labs., Inc. — Product Code KIS

K780009 is an FDA 510(k) premarket notification submitted by Northeast Biomedical Labs., Inc. for the device "GUINEA PIG WHOLE SERUM". The FDA issued a decision of Substantially Equivalent on January 20, 1978. The device falls under product code KIS (Sera, Animal And Human), a Class I device regulated under 21 CFR 864.2800. 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
Sera, Animal And Human
Device Class
Class I
Regulation Number
864.2800
Review Panel
PA
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)
  • K780005 — GOAT ANTI-INFLUENZA ANTISERA (January 20, 1978)
  • K780010 — GOAT ANTI-RUBELLA ANTISERA (January 20, 1978)
  • K780007 — GOAT ANTI-INFLUENZA ANTISERA (January 20, 1978)
  • K780004 — GOAT ANTI-INFLUENZA ANTISERA (January 20, 1978)
  • K780008 — GOAT ANTI-INFLUENZA ANTISERA (January 20, 1978)
  • K780006 — GOAT ANTI-INFLUENZA ANTISERA (January 20, 1978)

Other clearances for product code KIS

  • K881287 — ANIMAL AND HUMAN SERA (April 5, 1988)
  • K880471 — BOVINE CALF SERUM SUPPLEMENTED #A-2159 (April 4, 1988)
  • K880470 — BOVINE CALF SERUM CATALOG #A-2119 (April 1, 1988)
  • K872847 — SOLCOSERYL TISSUE CULTURE GROWTH SUPPLEMENT (August 10, 1987)
  • K870580 — MLC NORMAL SERUM (April 8, 1987)
  • K870938 — FETAL BOVINE SERUM (March 31, 1987)
  • K870464 — CHARACTERIZED FETAL BOVINE SERUM #A-1115 (March 24, 1987)
  • K870463 — DEFINED FETAL BOVINE SERUM #A-1111 (March 24, 1987)
  • K870467 — DEFINED CALF BOVINE SERUM SUPPLEMENTED #A-2151 (March 24, 1987)
  • K870469 — DEFINED EQUINE SERUM #A-3311 (March 24, 1987)

FDA data resources