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FDA 510(k)

TOTAL PROTEIN/ALBUMIN STANDARD

K-Number: K882116 · 1988-06-24

ApplicantVerichem Laboratories, Inc.
Decision Date1988-06-24
Product CodeJIX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

TOTAL PROTEIN/ALBUMIN STANDARD is the device name listed in this FDA 510(k) record. The listed applicant is Verichem Laboratories, Inc.. It received FDA 510(k) clearance on 1988-06-24 under 510(k) number K882116. 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 TOTAL PROTEIN/ALBUMIN STANDARD?

TOTAL PROTEIN/ALBUMIN STANDARD is a medical device that received FDA 510(k) clearance on 1988-06-24. The listed applicant is Verichem Laboratories, Inc.. The 510(k) number is K882116.

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

TOTAL PROTEIN/ALBUMIN STANDARD received FDA 510(k) clearance on 1988-06-24, under 510(k) number K882116.

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

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

What is the FDA product code for TOTAL PROTEIN/ALBUMIN STANDARD?

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

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Other records listing Verichem Laboratories, Inc. as applicant

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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

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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