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FDA 510(k)

CO2/CI STANDARDS

K-Number: K822289 · 1982-08-24

ApplicantGilford Diagnostics
Decision Date1982-08-24
Product CodeJIX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CO2/CI STANDARDS is the device name listed in this FDA 510(k) record. The listed applicant is Gilford Diagnostics. It received FDA 510(k) clearance on 1982-08-24 under 510(k) number K822289. 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 CO2/CI STANDARDS?

CO2/CI STANDARDS is a medical device that received FDA 510(k) clearance on 1982-08-24. The listed applicant is Gilford Diagnostics. The 510(k) number is K822289.

When did CO2/CI STANDARDS receive FDA 510(k) clearance?

CO2/CI STANDARDS received FDA 510(k) clearance on 1982-08-24, under 510(k) number K822289.

Who is the listed applicant for CO2/CI STANDARDS?

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

What is the FDA product code for CO2/CI STANDARDS?

The FDA product code for CO2/CI STANDARDS is JIX.

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Other records listing Gilford Diagnostics as applicant

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Related Devices (Code: JIX)

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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

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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