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510(k) K912357

3K-CAL HEMATOLOGY CALIBRATOR/MULTIPLE by R&D Systems, Inc. — Product Code KRX

K912357 is an FDA 510(k) premarket notification submitted by R&D Systems, Inc. for the device "3K-CAL HEMATOLOGY CALIBRATOR/MULTIPLE". The FDA issued a decision of Substantially Equivalent on July 9, 1991. The device falls under product code KRX (Calibrator For Cell Indices), a Class II device regulated under 21 CFR 864.8150. R&D Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 9, 1991
Date Received
May 28, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calibrator For Cell Indices
Device Class
Class II
Regulation Number
864.8150
Review Panel
HE
Submission Type

Other clearances by R&D Systems, Inc.

  • K160606 — BC-5D Hematology Control (September 1, 2016)
  • K130962 — R&D 5D RETIC HEMATOLOGY CONTROL (July 24, 2013)
  • K101578 — R&D SYSTEMS BODY FLUID-I HEMATOLOGY CONTROL (April 28, 2011)
  • K100050 — R & D SYSTEMS XERET HEMATOLOGY CONTROL (January 29, 2010)
  • K091433 — R&D SYSTEMS TETIC-I PLUS HEMOTOLOGY CONTROL (October 28, 2009)
  • K073178 — HCT EXTENDED HEMATOLOGY CONTROL, MODEL HCT004 (December 27, 2007)
  • K072846 — CSF AUTOMATED CONTROL, MODELS CSF001, CSF003 (November 26, 2007)
  • K072268 — HC WBC HEMATOLOGY CONTROL, MODEL: WBC00S (November 20, 2007)
  • K072096 — CBC-5D PLUS RETICS HEMATOLOGY CONTROL, MODELS: 5DR03, 5DR04 (August 20, 2007)
  • K070334 — R&D SICKLE QC CONTROL (March 29, 2007)

Other clearances for product code KRX

  • K160585 — XN CAL (December 22, 2016)
  • K141955 — XN CAL PF (December 5, 2014)
  • K141962 — XN CAL (December 5, 2014)
  • K120747 — XN CAL PF (October 22, 2012)
  • K120745 — XN CAL (October 19, 2012)
  • K111204 — CELL-DYN 22 PLUS CALIBRATOR (December 22, 2011)
  • K083200 — X-CAL (February 3, 2009)
  • K020469 — CAL-CHEX CD PLUS (April 4, 2002)
  • K003991 — CD-CAL PLUS CALIBRATOR (January 16, 2001)
  • K993375 — CDS LTX CONTROL LATEX PARTICLE SUSPENSION AND PRIMER (December 20, 1999)

FDA data resources