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FDA 510(k)

CDS 3-PD HEMATOLOGY CONTROLS

K-Number: K024173 · 2003-01-14

ApplicantClinical Diagnostic Solutions, Inc.
Decision Date2003-01-14
Product CodeJPK
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

CDS 3-PD HEMATOLOGY CONTROLS 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 2003-01-14 under 510(k) number K024173. The device is classified under product code JPK. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CDS 3-PD HEMATOLOGY CONTROLS?

CDS 3-PD HEMATOLOGY CONTROLS is a medical device that received FDA 510(k) clearance on 2003-01-14. The listed applicant is Clinical Diagnostic Solutions, Inc.. The 510(k) number is K024173.

When did CDS 3-PD HEMATOLOGY CONTROLS receive FDA 510(k) clearance?

CDS 3-PD HEMATOLOGY CONTROLS received FDA 510(k) clearance on 2003-01-14, under 510(k) number K024173.

Who is the listed applicant for CDS 3-PD HEMATOLOGY CONTROLS?

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 3-PD HEMATOLOGY CONTROLS?

The FDA product code for CDS 3-PD HEMATOLOGY CONTROLS is JPK.

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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.

K041130CDS HEMATOLOGY CALIBRATOR (CDS CAL)K993375CDS LTX CONTROL LATEX PARTICLE SUSPENSION AND PRIMER

Related Devices (Code: JPK)

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.

K160586XN-L CHECKStreckK160590XN CHECKStreckK160588XN CHECK BFStreckK160606BC-5D Hematology ControlR&D Systems, Inc.K130962R&D 5D RETIC HEMATOLOGY CONTROLR&D Systems, Inc.K120744XN CHECK BFStreck

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.

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