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FDA 510(k)

TOTAL PROTEIN PROCEDURE

K-Number: K861663 · 1986-06-13

ApplicantData Medical Associates, Inc.
Decision Date1986-06-13
Product CodeCEK
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

TOTAL PROTEIN PROCEDURE is the device name listed in this FDA 510(k) record. The listed applicant is Data Medical Associates, Inc.. It received FDA 510(k) clearance on 1986-06-13 under 510(k) number K861663. 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 TOTAL PROTEIN PROCEDURE?

TOTAL PROTEIN PROCEDURE is a medical device that received FDA 510(k) clearance on 1986-06-13. The listed applicant is Data Medical Associates, Inc.. The 510(k) number is K861663.

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

TOTAL PROTEIN PROCEDURE received FDA 510(k) clearance on 1986-06-13, under 510(k) number K861663.

Who is the listed applicant for TOTAL PROTEIN PROCEDURE?

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

What is the FDA product code for TOTAL PROTEIN PROCEDURE?

The FDA product code for TOTAL PROTEIN PROCEDURE is CEK.

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Other records listing Data Medical Associates, 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.

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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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