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510(k) K872847

SOLCOSERYL TISSUE CULTURE GROWTH SUPPLEMENT by Candace Lane Corp. — Product Code KIS

K872847 is an FDA 510(k) premarket notification submitted by Candace Lane Corp. for the device "SOLCOSERYL TISSUE CULTURE GROWTH SUPPLEMENT". The FDA issued a decision of Substantially Equivalent on August 10, 1987. 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
August 10, 1987
Date Received
July 20, 1987
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

  • 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)
  • 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