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510(k) K041130

CDS HEMATOLOGY CALIBRATOR (CDS CAL) by Clinical Diagnostic Solutions, Inc. — Product Code KRZ

K041130 is an FDA 510(k) premarket notification submitted by Clinical Diagnostic Solutions, Inc. for the device "CDS HEMATOLOGY CALIBRATOR (CDS CAL)". The FDA issued a decision of Substantially Equivalent on June 10, 2004. The device falls under product code KRZ (Calibrator For Hemoglobin And Hematocrit Measurement), a Class II device regulated under 21 CFR 864.8165. Clinical Diagnostic Solutions, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 10, 2004
Date Received
April 30, 2004
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calibrator For Hemoglobin And Hematocrit Measurement
Device Class
Class II
Regulation Number
864.8165
Review Panel
HE
Submission Type

Other clearances by Clinical Diagnostic Solutions, Inc.

  • K024173 — CDS 3-PD HEMATOLOGY CONTROLS (January 14, 2003)
  • K993375 — CDS LTX CONTROL LATEX PARTICLE SUSPENSION AND PRIMER (December 20, 1999)

Other clearances for product code KRZ

  • K052101 — C.F.A.S. (CALIBRATOR FOR AUTOMATED SYSTEMS) HBA1C (August 26, 2005)
  • K962864 — THB CAL STANDARD FOR IL CO-OXIMETERS/OXIMETERS (December 18, 1996)
  • K951071 — ALKO SLOPE THB SOLUTION FOR CORNING 280, 288 AND 2500 ANALYZERS (July 24, 1995)
  • K902892 — CELL-DYN CALIBRATOR (September 10, 1990)
  • K896921 — RAICHEM TM HEMOGLOBIN CALIBRATOR (January 25, 1990)
  • K893984 — HGB-CAL SET/MULTIPLE (August 15, 1989)
  • K883703 — MSI-CAL 7 (November 22, 1988)
  • K883850 — MSI-CAL 16 (November 22, 1988)
  • K883851 — MSI-CAL 8 (November 22, 1988)
  • K882600 — HEMOCUE HEMOGLOBIN CALIBRATOR (July 18, 1988)

FDA data resources