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FDA 510(k)

PROLYTE ELECTROLYTE ANALYZER

K-Number: K070104 · 2008-05-07

ApplicantDiamond Diagnostics, Inc.
Decision Date2008-05-07
Product CodeJGS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

PROLYTE 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 2008-05-07 under 510(k) number K070104. The device is classified under product code JGS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PROLYTE ELECTROLYTE ANALYZER?

PROLYTE ELECTROLYTE ANALYZER is a medical device that received FDA 510(k) clearance on 2008-05-07. The listed applicant is Diamond Diagnostics, Inc.. The 510(k) number is K070104.

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

PROLYTE ELECTROLYTE ANALYZER received FDA 510(k) clearance on 2008-05-07, under 510(k) number K070104.

Who is the listed applicant for PROLYTE 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 PROLYTE ELECTROLYTE ANALYZER?

The FDA product code for PROLYTE ELECTROLYTE ANALYZER is JGS.

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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 HIGHK121040SMARTLYTE ELECTROLYTE ANALYZERK121140PROLYTE ELECTROLYTE ANALYZERK120591DIAMOND TOKYO BOEKI ISE MODULE CALIBRATOR 1,2,1-2

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Related Devices (Code: JGS)

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.

K252475ABL90 FLEX PLUS SystemRadiometer Medicals ApsK230275i-STAT CG8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.K222438A-LYTE® Integrated Multisensor (IMT Na K Cl)Siemens Healthcare Diagnostics, Inc.K220977ISE Reagents, Glucose, CRP Latex, DxC 500 AU Clinical Chemistry AnalyzerBeckman Coulter Laboratory Systems (Suzhou) Co., Ltd.K213486GLP systems TrackAbbott LaboratoriesK200403Stat Profile Prime Plus Analyzer SystemNova Biomedical Corporation

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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