Home / 510(k) Clearances / K897060

510(k) K897060

CBC-CAL(TM) PLUS HEMATOLOGY CALIBRATOR/MULTIPLE by R&D Systems, Inc. — Product Code KSA

K897060 is an FDA 510(k) premarket notification submitted by R&D Systems, Inc. for the device "CBC-CAL(TM) PLUS HEMATOLOGY CALIBRATOR/MULTIPLE". The FDA issued a decision of Substantially Equivalent on January 2, 1990. The device falls under product code KSA (Calibrator For Red-Cell And White-Cell Counting), a Class II device regulated under 21 CFR 864.8185. R&D Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 2, 1990
Date Received
December 18, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calibrator For Red-Cell And White-Cell Counting
Device Class
Class II
Regulation Number
864.8185
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 KSA

  • K943268 — SCS-1000 (SYSMEX CALIBRATOR SYSTEM) (December 15, 1994)
  • K881161 — TECH-CAL(TM)/MULTIPLE (May 2, 1988)
  • K864664 — H-1 SETPOINT PLATELET AND RBC/WBC CALIBRATORS (February 6, 1987)
  • K854823 — CBC-CAL/MULTIPLE (February 13, 1986)
  • K844708 — TRI-COUNT CALIBRATOR (March 5, 1985)
  • K813530 — HEMOTOLOGY CALIBRATOR (February 22, 1982)
  • K813375 — HEMATOLOGY CALIBRATOR S-CAL (February 4, 1982)

FDA data resources