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FDA 510(k)

MCS TOTAL PROTEIN REAGENT

K-Number: K840290 · 1984-03-30

ApplicantMedilab Corp.
Decision Date1984-03-30
Product CodeCEK
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

MCS TOTAL PROTEIN REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Medilab Corp.. It received FDA 510(k) clearance on 1984-03-30 under 510(k) number K840290. 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 MCS TOTAL PROTEIN REAGENT?

MCS TOTAL PROTEIN REAGENT is a medical device that received FDA 510(k) clearance on 1984-03-30. The listed applicant is Medilab Corp.. The 510(k) number is K840290.

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

MCS TOTAL PROTEIN REAGENT received FDA 510(k) clearance on 1984-03-30, under 510(k) number K840290.

Who is the listed applicant for MCS TOTAL PROTEIN REAGENT?

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

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

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

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Other records listing Medilab 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.

K841862IMMU-TECK841863MONO-TECK840291MCS ALBUMIN REAGENTK840289LYSE-TECK832918PREGNA-TECK832527PREGNA-TEC

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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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