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510(k) K850208

FLOOD SOURCES & DOSE CALIBRATORS W/VARIOUS NUCLIDS by Syncor Intl. Corp. — Product Code IXD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 26, 1985
Date Received
January 18, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Source, Calibration, Sealed, Nuclear
Device Class
Class I
Regulation Number
892.1400
Review Panel
RA
Submission Type

Other clearances by Syncor Intl. Corp.

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  • K852023 — CESIUM 137 SOURCE, CSM-4, CSM-11, CSM-41 (August 21, 1985)
  • K850433 — CESIUM 137 ENDOMETRIAL SOURCE (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)
  • K850726 — WIRE CUTTERS, BRACHYTHERAPY-TABLE TOP & HAND HELD (March 26, 1985)
  • K850434 — CS137 SEALED SOURCES (March 26, 1985)
  • K850163 — IRIDIUM 192 WIRES (March 26, 1985)

Other clearances for product code IXD

  • K812235 — GOLD(AU 195) SPOT MARKER SOURCES (September 9, 1981)