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510(k) K870580

MLC NORMAL SERUM by Rjo Biologicals, Inc. — Product Code KIS

K870580 is an FDA 510(k) premarket notification submitted by Rjo Biologicals, Inc. for the device "MLC NORMAL SERUM". The FDA issued a decision of Substantially Equivalent on April 8, 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
April 8, 1987
Date Received
February 11, 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)
  • K872847 — SOLCOSERYL TISSUE CULTURE GROWTH SUPPLEMENT (August 10, 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)
  • K870469 — DEFINED EQUINE SERUM #A-3311 (March 24, 1987)
  • K870467 — DEFINED CALF BOVINE SERUM SUPPLEMENTED #A-2151 (March 24, 1987)
  • K870466 — DEFINED CALF BOVINE SERUM #A-2111 (March 24, 1987)

FDA data resources