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FDA 510(k)

ALBUMIN/TOTAL PROTEIN STANDARDS

K-Number: K802632 · 1980-12-11

ApplicantGilford Diagnostics
Decision Date1980-12-11
Product CodeJIX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ALBUMIN/TOTAL PROTEIN 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 1980-12-11 under 510(k) number K802632. 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 ALBUMIN/TOTAL PROTEIN STANDARDS?

ALBUMIN/TOTAL PROTEIN STANDARDS is a medical device that received FDA 510(k) clearance on 1980-12-11. The listed applicant is Gilford Diagnostics. The 510(k) number is K802632.

When did ALBUMIN/TOTAL PROTEIN STANDARDS receive FDA 510(k) clearance?

ALBUMIN/TOTAL PROTEIN STANDARDS received FDA 510(k) clearance on 1980-12-11, under 510(k) number K802632.

Who is the listed applicant for ALBUMIN/TOTAL PROTEIN 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 ALBUMIN/TOTAL PROTEIN STANDARDS?

The FDA product code for ALBUMIN/TOTAL PROTEIN STANDARDS is JIX.

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Other records listing Gilford Diagnostics as applicant

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K832094BILIRUBIN CALIBRATORS & CONTROLK831843GILCHEM TOTAL BILIRUBIN REAGENTK831844DIRECT BILIRUBIN REAGENTK823709TRIGLYCERIDE REAGENT (UV)K822739AHBDK822334BILIRUBIN CALIBRATORS

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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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