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510(k) K850207

PENPOINT, FLEXIBLE & SPOT MARKERS & RADOACTIVE RUL by Syncor Intl. Corp.

K850207 is an FDA 510(k) premarket notification submitted by Syncor Intl. Corp. for the device "PENPOINT, FLEXIBLE & SPOT MARKERS & RADOACTIVE RUL". The FDA issued a decision of Substantially Equivalent on March 1, 1985. Syncor Intl. Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 1, 1985
Date Received
January 18, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Other clearances by Syncor Intl. Corp.

  • K945825 — SECURE SAFETY INSERT (April 10, 1995)
  • K851828 — IRRADIATOR FOR BIOLOGICAL MATERIALS IBL-437-C (September 19, 1985)
  • 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)
  • K850163 — IRIDIUM 192 WIRES (March 26, 1985)
  • K850208 — FLOOD SOURCES & DOSE CALIBRATORS W/VARIOUS NUCLIDS (March 26, 1985)
  • K850434 — CS137 SEALED SOURCES (March 26, 1985)

FDA data resources