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FDA 510(k)

TMA BICARBONATE DILUENT

K-Number: K771044 · 1977-07-15

ApplicantHyland Therapeutic Div., Travenol Laboratories
Decision Date1977-07-15
Product CodeJJS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

TMA BICARBONATE DILUENT is the device name listed in this FDA 510(k) record. The listed applicant is Hyland Therapeutic Div., Travenol Laboratories. It received FDA 510(k) clearance on 1977-07-15 under 510(k) number K771044. 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 TMA BICARBONATE DILUENT?

TMA BICARBONATE DILUENT is a medical device that received FDA 510(k) clearance on 1977-07-15. The listed applicant is Hyland Therapeutic Div., Travenol Laboratories. The 510(k) number is K771044.

When did TMA BICARBONATE DILUENT receive FDA 510(k) clearance?

TMA BICARBONATE DILUENT received FDA 510(k) clearance on 1977-07-15, under 510(k) number K771044.

Who is the listed applicant for TMA BICARBONATE DILUENT?

The FDA 510(k) record lists Hyland Therapeutic Div., Travenol Laboratories as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TMA BICARBONATE DILUENT?

The FDA product code for TMA BICARBONATE DILUENT is JJS.

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Other records listing Hyland Therapeutic Div., Travenol Laboratories as applicant

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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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