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FDA 510(k)

SMAC REPLACEMENT/TOTAL PROTEIN HUMAN SER

K-Number: K800674 · 1980-05-28

ApplicantDiagnostic Solutions, Inc.
Decision Date1980-05-28
Product CodeCEK
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SMAC REPLACEMENT/TOTAL PROTEIN HUMAN SER is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Solutions, Inc.. It received FDA 510(k) clearance on 1980-05-28 under 510(k) number K800674. 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 SMAC REPLACEMENT/TOTAL PROTEIN HUMAN SER?

SMAC REPLACEMENT/TOTAL PROTEIN HUMAN SER is a medical device that received FDA 510(k) clearance on 1980-05-28. The listed applicant is Diagnostic Solutions, Inc.. The 510(k) number is K800674.

When did SMAC REPLACEMENT/TOTAL PROTEIN HUMAN SER receive FDA 510(k) clearance?

SMAC REPLACEMENT/TOTAL PROTEIN HUMAN SER received FDA 510(k) clearance on 1980-05-28, under 510(k) number K800674.

Who is the listed applicant for SMAC REPLACEMENT/TOTAL PROTEIN HUMAN SER?

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

What is the FDA product code for SMAC REPLACEMENT/TOTAL PROTEIN HUMAN SER?

The FDA product code for SMAC REPLACEMENT/TOTAL PROTEIN HUMAN SER is CEK.

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Other records listing Diagnostic Solutions, Inc. as applicant

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K934892RELIEF PLUS ONE REAGENT STRIP MODIFICATIONK924398UNI-CHECK REAGENT STRIPK921825QUICK-CHECK II REAGENT STRIPK800689REAGENT FOR DETERM. GLUTAMIC-PYRUVIC-K800681REAGENTS FOR DETERM. CO2 IN HUMAN SERUMK800691REAGENT FOR DETERM. LACTATE/DEHYDROGENAS

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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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