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510(k) K851828

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

K851828 is an FDA 510(k) premarket notification submitted by Syncor Intl. Corp. for the device "IRRADIATOR FOR BIOLOGICAL MATERIALS IBL-437-C". The FDA issued a decision of Substantially Equivalent on September 19, 1985. The device falls under product code MOT (Irradiator, Blood To Prevent Graft Versus Host Disease), a Class U device. Syncor Intl. Corp. has at least 10 other 510(k) clearances on record.

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)
  • 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)
  • 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)
  • K850726 — WIRE CUTTERS, BRACHYTHERAPY-TABLE TOP & HAND HELD (March 26, 1985)

Other clearances for product code MOT

  • K201177 — RadGil2 (August 17, 2020)
  • K181737 — Raycell MK1 (January 2, 2019)
  • K172087 — SANGRAY (October 27, 2017)
  • K161324 — Raycell Mk2 (August 12, 2016)
  • K082921 — RAD SOURCE X-RAY BLOOD IRRADIATOR, MODEL RS-3400 (February 17, 2009)
  • K051065 — RAYCELL X-RAY BLOOD IRRADIATOR (May 26, 2005)
  • K050963 — GAMMACELL 1000 ELITE AND GAMMACELL 3000 ELAN (May 20, 2005)
  • K032684 — RAYCELL (September 26, 2003)
  • K974210 — SHIELDED CABINET X-RAY RADIATION SOURCE DEVICE MODEL RS 3000 (March 30, 1998)
  • K963497 — GAMMACELL 3000 ELAN, VERSION 1.0 AND GAMMACELL 1000 ELITE, VERSION 1.0 (November 8, 1996)

FDA data resources