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FDA 510(k)

CONNECT. DIAG. TOTAL PROTEIN DIAG. REAGE

K-Number: K792340 · 1979-12-06

ApplicantConnecticut Diagnostics, Ltd.
Decision Date1979-12-06
Product CodeCEK
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CONNECT. DIAG. TOTAL PROTEIN DIAG. REAGE is the device name listed in this FDA 510(k) record. The listed applicant is Connecticut Diagnostics, Ltd.. It received FDA 510(k) clearance on 1979-12-06 under 510(k) number K792340. 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 CONNECT. DIAG. TOTAL PROTEIN DIAG. REAGE?

CONNECT. DIAG. TOTAL PROTEIN DIAG. REAGE is a medical device that received FDA 510(k) clearance on 1979-12-06. The listed applicant is Connecticut Diagnostics, Ltd.. The 510(k) number is K792340.

When did CONNECT. DIAG. TOTAL PROTEIN DIAG. REAGE receive FDA 510(k) clearance?

CONNECT. DIAG. TOTAL PROTEIN DIAG. REAGE received FDA 510(k) clearance on 1979-12-06, under 510(k) number K792340.

Who is the listed applicant for CONNECT. DIAG. TOTAL PROTEIN DIAG. REAGE?

The FDA 510(k) record lists Connecticut Diagnostics, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CONNECT. DIAG. TOTAL PROTEIN DIAG. REAGE?

The FDA product code for CONNECT. DIAG. TOTAL PROTEIN DIAG. REAGE is CEK.

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Other records listing Connecticut Diagnostics, Ltd. as applicant

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K905617VISI-STAPHK822500CDL LYSING REAGENTK822501CDL ISOTONIC DILUENTK822504CDL AUTO-LYSING REAGENTK811222INORGANIC PHOSPHORUS REAGENTSK801897GLUCOSE DIAGNOSTIC REAGENT

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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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