CDS Hematology Calibrator (CDS Cal)

FDA 510(k) K041130 · Clinical Diagnostic Solutions, Inc.

Substantially Equivalent

510(k) numberK041130

Submission

Device name
CDS Hematology Calibrator (CDS Cal)
Applicant
Clinical Diagnostic Solutions, Inc.
Plantation, FL, US
Received
April 30, 2004
Decision date
June 10, 2004
Decision
Substantially Equivalent (SESE)
Type
Abbreviated 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
KRZ – Calibrator For Hemoglobin And Hematocrit Measurement
Device class
Class II (moderate risk)
Regulation
21 CFR 864.8165
Specialty
Hematology

Other 510(k)s with product code KRZ

510(k)DeviceApplicantDecision
K052101C.F.A.S. (Calibrator for Automated Systems) HBA1CKRZ · Abbreviated Roche Diagnostics08/26/2005SE
K962864THB Cal Standard for Il Co-Oximeters/OximetersKRZ · Traditional Alko Diagnostic Corp.12/18/1996SE
K951071Alko Slope THB Solution for Corning 280, 288 and 2500 AnalyzersKRZ · Traditional Alko Diagnostic Corp.07/24/1995SE
K902892Cell-Dyn CalibratorKRZ · Traditional Unipath , Ltd.09/10/1990SE
K896921Raichem TM Hemoglobin CalibratorKRZ · Traditional Reagents Applications, Inc.01/25/1990SE
K893984Hgb-Cal Set/MultipleKRZ · Traditional R&D Systems, Inc.08/15/1989SE
K883851Msi-Cal 8KRZ · Traditional Medical Specialties, Inc.11/22/1988SE
K883850Msi-Cal 16KRZ · Traditional Medical Specialties, Inc.11/22/1988SE
K883703Msi-Cal 7KRZ · Traditional Medical Specialties, Inc.11/22/1988SE
K882600Hemocue Hemoglobin CalibratorKRZ · Traditional React and Co.07/18/1988SE

More from React and Co.

510(k)DeviceDecision
K024173CDS 3-PD Hematology ControlsJPK · Traditional 01/14/2003SE
K993375CDS LTX Control Latex Particle Suspension and PrimerKRX · Abbreviated 12/20/1999SE

Questions and answers

When was CDS Hematology Calibrator (CDS Cal) cleared by the FDA?

CDS Hematology Calibrator (CDS Cal) (K041130) received a 510(k) decision of Substantially Equivalent on June 10, 2004, 41 days after the submission was received.

What is the product code of K041130?

The FDA product code is KRZ – Calibrator For Hemoglobin And Hematocrit Measurement, a Class II (moderate risk) device regulated under 21 CFR 864.8165.