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FDA 510(k)

HC WBC HEMATOLOGY CONTROL, MODEL: WBC00S

K-Number: K072268 · 2007-11-20

ApplicantR&D Systems, Inc.
Decision Date2007-11-20
Product CodeJPK
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

HC WBC HEMATOLOGY CONTROL, MODEL: WBC00S 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 2007-11-20 under 510(k) number K072268. 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 HC WBC HEMATOLOGY CONTROL, MODEL: WBC00S?

HC WBC HEMATOLOGY CONTROL, MODEL: WBC00S is a medical device that received FDA 510(k) clearance on 2007-11-20. The listed applicant is R&D Systems, Inc.. The 510(k) number is K072268.

When did HC WBC HEMATOLOGY CONTROL, MODEL: WBC00S receive FDA 510(k) clearance?

HC WBC HEMATOLOGY CONTROL, MODEL: WBC00S received FDA 510(k) clearance on 2007-11-20, under 510(k) number K072268.

Who is the listed applicant for HC WBC HEMATOLOGY CONTROL, MODEL: WBC00S?

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 HC WBC HEMATOLOGY CONTROL, MODEL: WBC00S?

The FDA product code for HC WBC HEMATOLOGY CONTROL, MODEL: WBC00S 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 CONTROLK073178HCT EXTENDED HEMATOLOGY CONTROL, MODEL HCT004

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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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