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FDA 510(k)

GAS-TRAK 2 SYNTHETIC BLOOD GAS CONTROL

K-Number: K820705 · 1982-04-01

ApplicantUnited Diagnostics, Inc.
Decision Date1982-04-01
Product CodeJJS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

GAS-TRAK 2 SYNTHETIC BLOOD GAS CONTROL is the device name listed in this FDA 510(k) record. The listed applicant is United Diagnostics, Inc.. It received FDA 510(k) clearance on 1982-04-01 under 510(k) number K820705. 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 GAS-TRAK 2 SYNTHETIC BLOOD GAS CONTROL?

GAS-TRAK 2 SYNTHETIC BLOOD GAS CONTROL is a medical device that received FDA 510(k) clearance on 1982-04-01. The listed applicant is United Diagnostics, Inc.. The 510(k) number is K820705.

When did GAS-TRAK 2 SYNTHETIC BLOOD GAS CONTROL receive FDA 510(k) clearance?

GAS-TRAK 2 SYNTHETIC BLOOD GAS CONTROL received FDA 510(k) clearance on 1982-04-01, under 510(k) number K820705.

Who is the listed applicant for GAS-TRAK 2 SYNTHETIC BLOOD GAS CONTROL?

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

What is the FDA product code for GAS-TRAK 2 SYNTHETIC BLOOD GAS CONTROL?

The FDA product code for GAS-TRAK 2 SYNTHETIC BLOOD GAS CONTROL is JJS.

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Other records listing United 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.

K884977GAS TRAK PLUSK862278GAS-TRAKK844018GAS TRAK BRAND CO-OXIMETER CONTROLS 1,2 & 3K843986STAT-TRAK PLUS LIQUID CHEMISTRY CONTROLS 1,2 & 3K831389STAT-TRAK LIQUID ELECTROLYTE CONTROLK831814CALIBRATION STANDARD-HEMOGLOBIN

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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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