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FDA 510(k)

BIURET (COLORIMETRIC), TOTAL PROTEIN

K-Number: K864743 · 1987-01-13

ApplicantTech-Co, Inc.
Decision Date1987-01-13
Product CodeCEK
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BIURET (COLORIMETRIC), TOTAL PROTEIN is the device name listed in this FDA 510(k) record. The listed applicant is Tech-Co, Inc.. It received FDA 510(k) clearance on 1987-01-13 under 510(k) number K864743. 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 BIURET (COLORIMETRIC), TOTAL PROTEIN?

BIURET (COLORIMETRIC), TOTAL PROTEIN is a medical device that received FDA 510(k) clearance on 1987-01-13. The listed applicant is Tech-Co, Inc.. The 510(k) number is K864743.

When did BIURET (COLORIMETRIC), TOTAL PROTEIN receive FDA 510(k) clearance?

BIURET (COLORIMETRIC), TOTAL PROTEIN received FDA 510(k) clearance on 1987-01-13, under 510(k) number K864743.

Who is the listed applicant for BIURET (COLORIMETRIC), TOTAL PROTEIN?

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

What is the FDA product code for BIURET (COLORIMETRIC), TOTAL PROTEIN?

The FDA product code for BIURET (COLORIMETRIC), TOTAL PROTEIN is CEK.

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Other records listing Tech-Co, Inc. 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.

K921968IN VITRO DIAGNOSTIC REAGENT SET, INDIR. PREG. TESTK923376VISUAL HCG PREGNANCY TESTK920766T4 EIA BEAD ASSAYK920716DIRECT PREGNANCY TESTK902574POTASSIUM REAGENT SETK901561IRON/TOTAL IRON BINDING CAPACITY

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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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