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FDA 510(k)

WHOLE BLOOD GAS CONTROL

K-Number: K770950 · 1977-08-02

ApplicantDade, Baxter Travenol Diagnostics, Inc.
Decision Date1977-08-02
Product CodeJJS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

WHOLE BLOOD GAS CONTROL 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 1977-08-02 under 510(k) number K770950. The device is classified under product code JJS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WHOLE BLOOD GAS CONTROL?

WHOLE BLOOD GAS CONTROL is a medical device that received FDA 510(k) clearance on 1977-08-02. The listed applicant is Dade, Baxter Travenol Diagnostics, Inc.. The 510(k) number is K770950.

When did WHOLE BLOOD GAS CONTROL receive FDA 510(k) clearance?

WHOLE BLOOD GAS CONTROL received FDA 510(k) clearance on 1977-08-02, under 510(k) number K770950.

Who is the listed applicant for WHOLE BLOOD GAS CONTROL?

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?

The FDA product code for WHOLE BLOOD GAS CONTROL is JJS.

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Other records listing Dade, Baxter Travenol Diagnostics, 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.

K800296WHOLE BLOOD GAS CONTROL, LEVELS 1,2,&3K792606WHOLE BLOOD PLATELET CONTROL NORMAL,K792723BLOOD FLUID FILTERSK792607T3 UPTAKE (T3U) REAGENTSK792443TSH RADIOIMMUNOASSAYK792442FERRITIN RADIOIMMUNOASSAY

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Related Devices (Code: JJS)

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.

K152553CueSee HypoxicEurotrol B.V.K130415HIGH METABOLITE QUALICHECKRadiometer Medical ApsK130236RANGE + QUALICHECK LEVEL 1, RANGE + QUALICHECK LEVEL 2, RANGE + QUALICHECK LEVEL 3Radiometer Medical ApsK033063MISSION CONTROLSDiamond Diagnostics, Inc.K022525LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (RADIOMETER 700 SERIES) LEVELS, 1,2 AND 3, MODEL 507, 508, 509Bio-RadK022529LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (IL SYNTHESIS SERIES) LEVELS 1,2, AND 3, MODELS 667,668,669Bio-Rad

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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