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FDA 510(k)

HGB-CONTROL SET/MULTIPLE

K-Number: K893985 · 1989-08-15

ApplicantR&D Systems, Inc.
Decision Date1989-08-15
Product CodeGGM
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

HGB-CONTROL SET/MULTIPLE 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 1989-08-15 under 510(k) number K893985. 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 HGB-CONTROL SET/MULTIPLE?

HGB-CONTROL SET/MULTIPLE is a medical device that received FDA 510(k) clearance on 1989-08-15. The listed applicant is R&D Systems, Inc.. The 510(k) number is K893985.

When did HGB-CONTROL SET/MULTIPLE receive FDA 510(k) clearance?

HGB-CONTROL SET/MULTIPLE received FDA 510(k) clearance on 1989-08-15, under 510(k) number K893985.

Who is the listed applicant for HGB-CONTROL SET/MULTIPLE?

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 HGB-CONTROL SET/MULTIPLE?

The FDA product code for HGB-CONTROL SET/MULTIPLE is GGM.

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Other records listing R&D Systems, Inc. as applicant

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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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