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FDA 510(k)

R & D SYSTEMS' WHOLE BLOOD FLOW CONTROL, (R & D - WBFC)

K-Number: K961610 · 1996-07-01

ApplicantR&D Systems, Inc.
Decision Date1996-07-01
Product CodeGKZ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

R & D SYSTEMS' WHOLE BLOOD FLOW CONTROL, (R & D - WBFC) 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 1996-07-01 under 510(k) number K961610. The device is classified under product code GKZ. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the R & D SYSTEMS' WHOLE BLOOD FLOW CONTROL, (R & D - WBFC)?

R & D SYSTEMS' WHOLE BLOOD FLOW CONTROL, (R & D - WBFC) is a medical device that received FDA 510(k) clearance on 1996-07-01. The listed applicant is R&D Systems, Inc.. The 510(k) number is K961610.

When did R & D SYSTEMS' WHOLE BLOOD FLOW CONTROL, (R & D - WBFC) receive FDA 510(k) clearance?

R & D SYSTEMS' WHOLE BLOOD FLOW CONTROL, (R & D - WBFC) received FDA 510(k) clearance on 1996-07-01, under 510(k) number K961610.

Who is the listed applicant for R & D SYSTEMS' WHOLE BLOOD FLOW CONTROL, (R & D - WBFC)?

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 R & D SYSTEMS' WHOLE BLOOD FLOW CONTROL, (R & D - WBFC)?

The FDA product code for R & D SYSTEMS' WHOLE BLOOD FLOW CONTROL, (R & D - WBFC) is GKZ.

Related Clinical Trials

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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: GKZ)

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.

K260781Yumizen H550HORIBA ABX SASK253212XR-Series (XR-10, XR-20) Automated Hematology AnalyzersSysmex America, Inc.K243348Athelas HomeAthelas, Inc.K251249Tru Hematology TestTruvian Sciences, Inc.K250943Sysmex XR-Series (XR-10) Automated Hematology AnalyzerSysmex America, Inc.K251371Sysmex XR-Series (XR-20) Automated Hematology AnalyzerSysmex America, 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.

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