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510(k) K851828

IRRADIATOR FOR BIOLOGICAL MATERIALS IBL-437-C by Syncor Intl. Corp. — Product Code MOT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 19, 1985
Date Received
April 26, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Irradiator, Blood To Prevent Graft Versus Host Disease
Device Class
Class U
Regulation Number
Review Panel
RA
Submission Type

Other clearances by Syncor Intl. Corp.

  • K945825 — SECURE SAFETY INSERT (April 10, 1995)
  • K850433 — CESIUM 137 ENDOMETRIAL SOURCE (August 21, 1985)
  • K852023 — CESIUM 137 SOURCE, CSM-4, CSM-11, CSM-41 (August 21, 1985)
  • K852665 — SYNCOR TRICH DIRECT IMMUNOFLUORESCENCE ASSAY (August 13, 1985)
  • K851033 — SYNCORTECH CHLAMYDIA DIRECT SPECIMAN KIT (June 21, 1985)
  • K844735 — PTH-RIA (April 29, 1985)
  • K850434 — CS137 SEALED SOURCES (March 26, 1985)
  • K850163 — IRIDIUM 192 WIRES (March 26, 1985)
  • K850726 — WIRE CUTTERS, BRACHYTHERAPY-TABLE TOP & HAND HELD (March 26, 1985)
  • K850208 — FLOOD SOURCES & DOSE CALIBRATORS W/VARIOUS NUCLIDS (March 26, 1985)

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