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FDA 510(k)

HCT EXTENDED HEMATOLOGY CONTROL, MODEL HCT004

K-Number: K073178 · 2007-12-27

ApplicantR&D Systems, Inc.
Decision Date2007-12-27
Product CodeJPK
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

HCT EXTENDED HEMATOLOGY CONTROL, MODEL HCT004 is the device name listed in this FDA 510(k) record. The listed applicant is R&D Systems, Inc.. It received FDA 510(k) clearance on 2007-12-27 under 510(k) number K073178. 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 HCT EXTENDED HEMATOLOGY CONTROL, MODEL HCT004?

HCT EXTENDED HEMATOLOGY CONTROL, MODEL HCT004 is a medical device that received FDA 510(k) clearance on 2007-12-27. The listed applicant is R&D Systems, Inc.. The 510(k) number is K073178.

When did HCT EXTENDED HEMATOLOGY CONTROL, MODEL HCT004 receive FDA 510(k) clearance?

HCT EXTENDED HEMATOLOGY CONTROL, MODEL HCT004 received FDA 510(k) clearance on 2007-12-27, under 510(k) number K073178.

Who is the listed applicant for HCT EXTENDED HEMATOLOGY CONTROL, MODEL HCT004?

The FDA 510(k) record lists R&D Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HCT EXTENDED HEMATOLOGY CONTROL, MODEL HCT004?

The FDA product code for HCT EXTENDED HEMATOLOGY CONTROL, MODEL HCT004 is JPK.

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Other records listing R&D Systems, 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.

K160606BC-5D Hematology ControlK130962R&D 5D RETIC HEMATOLOGY CONTROLK101578R&D SYSTEMS BODY FLUID-I HEMATOLOGY CONTROLK100050R & D SYSTEMS XERET HEMATOLOGY CONTROLK091433R&D SYSTEMS TETIC-I PLUS HEMOTOLOGY CONTROLK072846CSF AUTOMATED CONTROL, MODELS CSF001, CSF003

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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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