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FDA 510(k)

DEMAND TOTAL PROTEIN

K-Number: K863301 · 1986-09-26

ApplicantCooper Biomedical, Inc.
Decision Date1986-09-26
Product CodeCEK
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DEMAND TOTAL PROTEIN is the device name listed in this FDA 510(k) record. The listed applicant is Cooper Biomedical, Inc.. It received FDA 510(k) clearance on 1986-09-26 under 510(k) number K863301. 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 DEMAND TOTAL PROTEIN?

DEMAND TOTAL PROTEIN is a medical device that received FDA 510(k) clearance on 1986-09-26. The listed applicant is Cooper Biomedical, Inc.. The 510(k) number is K863301.

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

DEMAND TOTAL PROTEIN received FDA 510(k) clearance on 1986-09-26, under 510(k) number K863301.

Who is the listed applicant for DEMAND TOTAL PROTEIN?

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

What is the FDA product code for DEMAND TOTAL PROTEIN?

The FDA product code for DEMAND TOTAL PROTEIN is CEK.

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Other records listing Cooper Biomedical, Inc. as applicant

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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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