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FDA 510(k)

TOTAL PROTEIN OR TP

K-Number: K971524 · 1997-05-16

ApplicantCarolina Liquid Chemistries Corp.
Decision Date1997-05-16
Product CodeCEK
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

TOTAL PROTEIN OR TP is the device name listed in this FDA 510(k) record. The listed applicant is Carolina Liquid Chemistries Corp.. It received FDA 510(k) clearance on 1997-05-16 under 510(k) number K971524. 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 OR TP?

TOTAL PROTEIN OR TP is a medical device that received FDA 510(k) clearance on 1997-05-16. The listed applicant is Carolina Liquid Chemistries Corp.. The 510(k) number is K971524.

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

TOTAL PROTEIN OR TP received FDA 510(k) clearance on 1997-05-16, under 510(k) number K971524.

Who is the listed applicant for TOTAL PROTEIN OR TP?

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

What is the FDA product code for TOTAL PROTEIN OR TP?

The FDA product code for TOTAL PROTEIN OR TP is CEK.

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Other records listing Carolina Liquid Chemistries 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.

K213211Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Enzyme Immunoassay (COCM) Test SystemK972073TOTAL BILIRUBIN REAGENTK971907CALCIUM REAGENTK971324TRIGLYCERIDES, TG, OR TRIGK971967BUNK971908CREA OR CREATININE

View all 18 devices →

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.K961864CSF/URINE TOTAL PROTEINTeco DiagnosticsK955905STC DIAGNOSTICS AUTO-LYTE URINARY PROTEIN ASSAYSolarcare Technologies Corp,Inc.K955936TOTAL PROTEIN REAGENTDerma Media Lab., 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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