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510(k) K880470

BOVINE CALF SERUM CATALOG #A-2119 by Hyclone Laboratories, Inc. — Product Code KIS

K880470 is an FDA 510(k) premarket notification submitted by Hyclone Laboratories, Inc. for the device "BOVINE CALF SERUM CATALOG #A-2119". The FDA issued a decision of Substantially Equivalent on April 1, 1988. The device falls under product code KIS (Sera, Animal And Human), a Class I device regulated under 21 CFR 864.2800. Hyclone Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 1, 1988
Date Received
February 3, 1988
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 Hyclone Laboratories, Inc.

  • K884654 — ALPHACALF SERUM (November 30, 1988)
  • K880471 — BOVINE CALF SERUM SUPPLEMENTED #A-2159 (April 4, 1988)
  • K870938 — FETAL BOVINE SERUM (March 31, 1987)
  • K870469 — DEFINED EQUINE SERUM #A-3311 (March 24, 1987)
  • K870466 — DEFINED CALF BOVINE SERUM #A-2111 (March 24, 1987)
  • K870468 — ADULT BOVINE SERUM (March 24, 1987)
  • K870463 — DEFINED FETAL BOVINE SERUM #A-1111 (March 24, 1987)
  • K870465 — 6/40 FETAL BOVINE SERUM #A-1110 (March 24, 1987)
  • K870464 — CHARACTERIZED FETAL BOVINE SERUM #A-1115 (March 24, 1987)
  • K870467 — DEFINED CALF BOVINE SERUM SUPPLEMENTED #A-2151 (March 24, 1987)

Other clearances for product code KIS

  • K881287 — ANIMAL AND HUMAN SERA (April 5, 1988)
  • K880471 — BOVINE CALF SERUM SUPPLEMENTED #A-2159 (April 4, 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)
  • K870467 — DEFINED CALF BOVINE SERUM SUPPLEMENTED #A-2151 (March 24, 1987)
  • K870469 — DEFINED EQUINE SERUM #A-3311 (March 24, 1987)
  • K870463 — DEFINED FETAL BOVINE SERUM #A-1111 (March 24, 1987)
  • K870466 — DEFINED CALF BOVINE SERUM #A-2111 (March 24, 1987)

FDA data resources