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FDA 510(k)

SYNERMED TOTAL PROTEIN REAGENT KIT

K-Number: K903511 · 1990-09-07

ApplicantSynermed, Inc.
Decision Date1990-09-07
Product CodeCEK
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SYNERMED TOTAL PROTEIN REAGENT KIT is the device name listed in this FDA 510(k) record. The listed applicant is Synermed, Inc.. It received FDA 510(k) clearance on 1990-09-07 under 510(k) number K903511. 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 SYNERMED TOTAL PROTEIN REAGENT KIT?

SYNERMED TOTAL PROTEIN REAGENT KIT is a medical device that received FDA 510(k) clearance on 1990-09-07. The listed applicant is Synermed, Inc.. The 510(k) number is K903511.

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

SYNERMED TOTAL PROTEIN REAGENT KIT received FDA 510(k) clearance on 1990-09-07, under 510(k) number K903511.

Who is the listed applicant for SYNERMED TOTAL PROTEIN REAGENT KIT?

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

What is the FDA product code for SYNERMED TOTAL PROTEIN REAGENT KIT?

The FDA product code for SYNERMED TOTAL PROTEIN REAGENT KIT is CEK.

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Other records listing Synermed, 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.

K973109SYNERMED NEAR-INFRARED DIRECT BILIRUBIN REAGENT KITK972716SYNERMED TOTAL BILIRUBIN REAGENT KITK971491SYNERMED IR 200 CHEMISTRY ANALYZERK962479SYNERMED ISE REAGENTSK963939SYNERMED DIRECT BILIRUBIN REAGENT KITK960793SYNERMED ENZYMATIC CO2 REAGENT KIT

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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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