Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

CDS HEMATOLOGY CALIBRATOR (CDS CAL)

K-Number: K041130 · 2004-06-10

ApplicantClinical Diagnostic Solutions, Inc.
Decision Date2004-06-10
Product CodeKRZ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

CDS HEMATOLOGY CALIBRATOR (CDS CAL) is the device name listed in this FDA 510(k) record. The listed applicant is Clinical Diagnostic Solutions, Inc.. It received FDA 510(k) clearance on 2004-06-10 under 510(k) number K041130. The device is classified under product code KRZ. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CDS HEMATOLOGY CALIBRATOR (CDS CAL)?

CDS HEMATOLOGY CALIBRATOR (CDS CAL) is a medical device that received FDA 510(k) clearance on 2004-06-10. The listed applicant is Clinical Diagnostic Solutions, Inc.. The 510(k) number is K041130.

When did CDS HEMATOLOGY CALIBRATOR (CDS CAL) receive FDA 510(k) clearance?

CDS HEMATOLOGY CALIBRATOR (CDS CAL) received FDA 510(k) clearance on 2004-06-10, under 510(k) number K041130.

Who is the listed applicant for CDS HEMATOLOGY CALIBRATOR (CDS CAL)?

The FDA 510(k) record lists Clinical Diagnostic Solutions, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CDS HEMATOLOGY CALIBRATOR (CDS CAL)?

The FDA product code for CDS HEMATOLOGY CALIBRATOR (CDS CAL) is KRZ.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Clinical Diagnostic Solutions, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K024173CDS 3-PD HEMATOLOGY CONTROLSK993375CDS LTX CONTROL LATEX PARTICLE SUSPENSION AND PRIMER

Related Devices (Code: KRZ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K052101C.F.A.S. (CALIBRATOR FOR AUTOMATED SYSTEMS) HBA1CRoche DiagnosticsK962864THB CAL STANDARD FOR IL CO-OXIMETERS/OXIMETERSAlko Diagnostic Corp.K951071ALKO SLOPE THB SOLUTION FOR CORNING 280, 288 AND 2500 ANALYZERSAlko Diagnostic Corp.K902892CELL-DYN CALIBRATORUnipath , Ltd.K896921RAICHEM TM HEMOGLOBIN CALIBRATORReagents Applications, Inc.K893984HGB-CAL SET/MULTIPLER&D Systems, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑