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FDA 510(k)

R&D HGB/GLC WHOLE BLOOD CONTROL

K-Number: K993321 · 1999-11-12

ApplicantR&D Systems, Inc.
Decision Date1999-11-12
Product CodeGGM
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

R&D HGB/GLC WHOLE BLOOD CONTROL 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 1999-11-12 under 510(k) number K993321. The device is classified under product code GGM. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the R&D HGB/GLC WHOLE BLOOD CONTROL?

R&D HGB/GLC WHOLE BLOOD CONTROL is a medical device that received FDA 510(k) clearance on 1999-11-12. The listed applicant is R&D Systems, Inc.. The 510(k) number is K993321.

When did R&D HGB/GLC WHOLE BLOOD CONTROL receive FDA 510(k) clearance?

R&D HGB/GLC WHOLE BLOOD CONTROL received FDA 510(k) clearance on 1999-11-12, under 510(k) number K993321.

Who is the listed applicant for R&D HGB/GLC WHOLE BLOOD CONTROL?

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 HGB/GLC WHOLE BLOOD CONTROL?

The FDA product code for R&D HGB/GLC WHOLE BLOOD CONTROL is GGM.

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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: GGM)

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.

K192842HemoTrol Duo Low, HemoTrol Duo Normal, HemoTrol Duo HighEurotrol B.V.K182744HemoTrol WB - Low, HemoTrol WB - Normal, HemoTrol WB - HighEurotrol B.V.K070546LYPHOCHEK DIABETES CONTROLBio-Rad LaboratoriesK070334R&D SICKLE QC CONTROLR&D Systems, Inc.K052838LIQUICHEK DIABETES CONTROL, LEVEL 1,2,3,4Bio-RadK032791GLYCOHEMOSURE HBA1C CONTROLQuantimetrix Corp.

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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