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FDA 510(k)

COULTER TOTAL PROTEIN REAGENT

K-Number: K897166 · 1990-02-23

ApplicantCoulter Electronics, Inc.
Decision Date1990-02-23
Product CodeCEK
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

COULTER TOTAL PROTEIN REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Coulter Electronics, Inc.. It received FDA 510(k) clearance on 1990-02-23 under 510(k) number K897166. 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 COULTER TOTAL PROTEIN REAGENT?

COULTER TOTAL PROTEIN REAGENT is a medical device that received FDA 510(k) clearance on 1990-02-23. The listed applicant is Coulter Electronics, Inc.. The 510(k) number is K897166.

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

COULTER TOTAL PROTEIN REAGENT received FDA 510(k) clearance on 1990-02-23, under 510(k) number K897166.

Who is the listed applicant for COULTER TOTAL PROTEIN REAGENT?

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

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

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

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Other records listing Coulter Electronics, Inc. as applicant

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K923951CD8 CYTOSPHERES KITK930119COULTER RETIC-C CELL CONTROLK921279CD4 CYTOSPHERES KITK923530COULTER MULTI-Q-PREPK922181COULTER MH009K922704COULTER MAXM W/ AUTOLOADER

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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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