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FDA 510(k)

WHOLE BLOOD GAS CONTROL, LEVELS 1,2,&3

K-Number: K800296 · 1980-03-05

ApplicantDade, Baxter Travenol Diagnostics, Inc.
Decision Date1980-03-05
Product CodeGGM
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

WHOLE BLOOD GAS CONTROL, LEVELS 1,2,&3 is the device name listed in this FDA 510(k) record. The listed applicant is Dade, Baxter Travenol Diagnostics, Inc.. It received FDA 510(k) clearance on 1980-03-05 under 510(k) number K800296. 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 WHOLE BLOOD GAS CONTROL, LEVELS 1,2,&3?

WHOLE BLOOD GAS CONTROL, LEVELS 1,2,&3 is a medical device that received FDA 510(k) clearance on 1980-03-05. The listed applicant is Dade, Baxter Travenol Diagnostics, Inc.. The 510(k) number is K800296.

When did WHOLE BLOOD GAS CONTROL, LEVELS 1,2,&3 receive FDA 510(k) clearance?

WHOLE BLOOD GAS CONTROL, LEVELS 1,2,&3 received FDA 510(k) clearance on 1980-03-05, under 510(k) number K800296.

Who is the listed applicant for WHOLE BLOOD GAS CONTROL, LEVELS 1,2,&3?

The FDA 510(k) record lists Dade, Baxter Travenol Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for WHOLE BLOOD GAS CONTROL, LEVELS 1,2,&3?

The FDA product code for WHOLE BLOOD GAS CONTROL, LEVELS 1,2,&3 is GGM.

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Other records listing Dade, Baxter Travenol Diagnostics, 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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