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510(k) K860752

GOAT SERUM (29-391-54) by Flow Laboratories, Inc. — Product Code KIS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 10, 1986
Date Received
February 28, 1986
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 Flow Laboratories, Inc.

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  • K861791 — PENICILLIN-STREPTOMYCIN-FUNGIZONE (May 20, 1986)
  • K861824 — GENTAMICIN SULFATE SOLUTION (10MG GENTAMICIN) (May 20, 1986)
  • K860762 — GAMMA-FREE HORSE SERUM (March 10, 1986)
  • K850908 — TITERTEK MICROITTRATION EQUIP. HANDIWASH 110 12CHA (March 25, 1985)
  • K844419 — TITERTEK MULTISKAN MSS/340 (March 21, 1985)
  • K844418 — TITERTEK MULTISKAN MCC (March 21, 1985)
  • K844567 — TITERTEK TWINREADER 78-630-00 (March 21, 1985)

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)
  • 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)
  • K870465 — 6/40 FETAL BOVINE SERUM #A-1110 (March 24, 1987)