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FDA 510(k)

BLOOD GAS ANALYZER-CALIBRATION GAS

K-Number: K770494 · 1977-04-15

ApplicantGardner Cryogenics
Decision Date1977-04-15
Product CodeJIX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BLOOD GAS ANALYZER-CALIBRATION GAS is the device name listed in this FDA 510(k) record. The listed applicant is Gardner Cryogenics. It received FDA 510(k) clearance on 1977-04-15 under 510(k) number K770494. The device is classified under product code JIX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BLOOD GAS ANALYZER-CALIBRATION GAS?

BLOOD GAS ANALYZER-CALIBRATION GAS is a medical device that received FDA 510(k) clearance on 1977-04-15. The listed applicant is Gardner Cryogenics. The 510(k) number is K770494.

When did BLOOD GAS ANALYZER-CALIBRATION GAS receive FDA 510(k) clearance?

BLOOD GAS ANALYZER-CALIBRATION GAS received FDA 510(k) clearance on 1977-04-15, under 510(k) number K770494.

Who is the listed applicant for BLOOD GAS ANALYZER-CALIBRATION GAS?

The FDA 510(k) record lists Gardner Cryogenics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BLOOD GAS ANALYZER-CALIBRATION GAS?

The FDA product code for BLOOD GAS ANALYZER-CALIBRATION GAS is JIX.

Related Clinical Trials

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.

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Other records listing Gardner Cryogenics 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.

K781523PFT GASES

Related Devices (Code: JIX)

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.

K161140VITROS Chemistry Products Calibrator Kit 3Ortho-Clinical Diagnostics, Inc.K133330C.F.A.S. PROTEINS, C.F.A.S. PAC, PRECICONTROL CLINCHEM MULTI 1 & 2, PRECINORM PROTEIN & PRECIPATH PROTEINRoche DiagnosticsK130765ELITECH CLINICAL SYSTEMS ELICAL 2; ELITECH CLINICAL SYSTEMS ELITROL I, ELITECH CLINICAL SYSTEMS ELITROL IIElitechgroupK123321DIMENSION CHEMISTRY III CALIBRATORYSiemens Healthcare DiagnosticsK123372ABBOTT LIPID MULTI CONSTITUENT CALIBRATORAbbott LaboratoriesK122398RAPIDPOINT 500 SYSTEM MEASUREMENT CARTRIDGE WITH CALIBRATORSSiemens Healthcare Diagnostics, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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