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FDA 510(k)

HICHEM TOTAL PROTEIN REAGENT

K-Number: K992846 · 1999-10-18

ApplicantElan Holdings, Inc.
Decision Date1999-10-18
Product CodeCEK
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

HICHEM TOTAL PROTEIN REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Elan Holdings, Inc.. It received FDA 510(k) clearance on 1999-10-18 under 510(k) number K992846. The device is classified under product code CEK. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HICHEM TOTAL PROTEIN REAGENT?

HICHEM TOTAL PROTEIN REAGENT is a medical device that received FDA 510(k) clearance on 1999-10-18. The listed applicant is Elan Holdings, Inc.. The 510(k) number is K992846.

When did HICHEM TOTAL PROTEIN REAGENT receive FDA 510(k) clearance?

HICHEM TOTAL PROTEIN REAGENT received FDA 510(k) clearance on 1999-10-18, under 510(k) number K992846.

Who is the listed applicant for HICHEM TOTAL PROTEIN REAGENT?

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

What is the FDA product code for HICHEM TOTAL PROTEIN REAGENT?

The FDA product code for HICHEM TOTAL PROTEIN REAGENT is CEK.

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Related Devices (Code: CEK)

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.

K973108TOTAL PROTEIN (MICRO) ASSAY, CATALOGUE NUMBER 450-50Diagnostic Chemicals , Ltd.K980042CARESIDE TOTAL PROTEINExigent Diagnostics, Inc.K971524TOTAL PROTEIN OR TPCarolina Liquid Chemistries Corp.K961864CSF/URINE TOTAL PROTEINTeco DiagnosticsK955905STC DIAGNOSTICS AUTO-LYTE URINARY PROTEIN ASSAYSolarcare Technologies Corp,Inc.K955936TOTAL PROTEIN REAGENTDerma Media Lab., 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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