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FDA 510(k)

SMARTLYTE ELECTROLYTE ANALYZER

K-Number: K121040 · 2012-08-30

ApplicantDiamond Diagnostics, Inc.
Decision Date2012-08-30
Product CodeCEM
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SMARTLYTE ELECTROLYTE ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Diamond Diagnostics, Inc.. It received FDA 510(k) clearance on 2012-08-30 under 510(k) number K121040. The device is classified under product code CEM. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SMARTLYTE ELECTROLYTE ANALYZER?

SMARTLYTE ELECTROLYTE ANALYZER is a medical device that received FDA 510(k) clearance on 2012-08-30. The listed applicant is Diamond Diagnostics, Inc.. The 510(k) number is K121040.

When did SMARTLYTE ELECTROLYTE ANALYZER receive FDA 510(k) clearance?

SMARTLYTE ELECTROLYTE ANALYZER received FDA 510(k) clearance on 2012-08-30, under 510(k) number K121040.

Who is the listed applicant for SMARTLYTE ELECTROLYTE ANALYZER?

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

What is the FDA product code for SMARTLYTE ELECTROLYTE ANALYZER?

The FDA product code for SMARTLYTE ELECTROLYTE ANALYZER is CEM.

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Other records listing Diamond Diagnostics, 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.

K200544SmartLyte® Plus Electrolyte Analyzer Na+/K+/Cl-/Ca++/Li+K124009MISSION CLINICHECK ASSAYED CHEMISTRY CONTROLS, LEVEL 1, MISSION CLINICHECK ASSAYED CHEMISTRY CONTROLS LEVEL 2, MISSION CK121027DIAMOND CALIBRATOR LOW, DIAMOND CALIBRATOR HIGHK121140PROLYTE ELECTROLYTE ANALYZERK120591DIAMOND TOKYO BOEKI ISE MODULE CALIBRATOR 1,2,1-2K103364MISSION CLINICHECK ASSAYED CHEMISTRY CONTROLS, LEVEL 1, LEVEL 2, DUAL LEVEL

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Related Devices (Code: CEM)

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.

K253491ISE indirect K for Gen.2; ISE indirect Na for Gen.2; ISE indirect Cl for Gen.2; cobas pro integrated solutionsRoche DiagnosticsK241037ABL90 FLEX PLUS SystemRadiometer Medicals ApsK220396EasyStat 300Medica CorporationK230890ISE ElectrodesRandox Laboratories, Ltd.K200544SmartLyte® Plus Electrolyte Analyzer Na+/K+/Cl-/Ca++/Li+Diamond Diagnostics, Inc.K121012FLEXLAB 3.6, ACCELERATOR A3600Inpeco S.P.A.

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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