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510(k) K881287

ANIMAL AND HUMAN SERA by Cell Culture Laboratories — Product Code KIS

K881287 is an FDA 510(k) premarket notification submitted by Cell Culture Laboratories for the device "ANIMAL AND HUMAN SERA". The FDA issued a decision of Substantially Equivalent on April 5, 1988. The device falls under product code KIS (Sera, Animal And Human), a Class I device regulated under 21 CFR 864.2800.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 5, 1988
Date Received
March 28, 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 for product code KIS

  • 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)
  • 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