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510(k) K865027

IRRADIATOR FOR BIOLOGICAL MATERIALS, IBL-137C by Cis-Us, Inc. — Product Code MOT

K865027 is an FDA 510(k) premarket notification submitted by Cis-Us, Inc. for the device "IRRADIATOR FOR BIOLOGICAL MATERIALS, IBL-137C". The FDA issued a decision of Substantially Equivalent on February 26, 1987. The device falls under product code MOT (Irradiator, Blood To Prevent Graft Versus Host Disease), a Class U device. Cis-Us, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 26, 1987
Date Received
December 23, 1986
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 Cis-Us, Inc.

  • K951708 — ELSA-HCT (September 5, 1995)
  • K950211 — ELSA-PTH (April 13, 1995)
  • K890799 — CURIETRON 192 HIGH DOSE RATE (October 27, 1989)
  • K882449 — CESIUM 137 SOURCE, MODEL CSM-40 (April 14, 1989)
  • K871502 — PERSONNEL PROTECTIVE SHIELD (May 8, 1987)
  • K863778 — VENTICIS II (October 27, 1986)
  • K860823 — ELSA-PROL IMMUNORADIOMETRIC ASSAY KIT (August 19, 1986)
  • K860824 — TSHK-NN RIA KIT (April 28, 1986)

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