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FDA 510(k)

TP BIURET REAGENT

K-Number: K852006 · 1985-06-10

ApplicantAlpkem Corp.
Decision Date1985-06-10
Product CodeCEK
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

TP BIURET REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Alpkem Corp.. It received FDA 510(k) clearance on 1985-06-10 under 510(k) number K852006. 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 TP BIURET REAGENT?

TP BIURET REAGENT is a medical device that received FDA 510(k) clearance on 1985-06-10. The listed applicant is Alpkem Corp.. The 510(k) number is K852006.

When did TP BIURET REAGENT receive FDA 510(k) clearance?

TP BIURET REAGENT received FDA 510(k) clearance on 1985-06-10, under 510(k) number K852006.

Who is the listed applicant for TP BIURET REAGENT?

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

What is the FDA product code for TP BIURET REAGENT?

The FDA product code for TP BIURET REAGENT is CEK.

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Other records listing Alpkem Corp. 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.

K894011TOTAL GALACTOSEK891070PHENYLALANINE (NINHYDRIN REACTION)K890334TOTAL CHOLESTEROL REAGENTK890337TRIGLYCERIDES - GPO REAGENTK890336GLUCOSE (GOD) REAGENTK890332RFA/2 RAPID FLOW ANALYZER W/COMPUTER

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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.

K992846HICHEM TOTAL PROTEIN REAGENTElan Holdings, Inc.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.

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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