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FDA 510(k)

OSMETECH OPTI R CRITICAL CARE ANALYZER, MODEL GD7044

K-Number: K061730 · 2006-08-04

ApplicantOsmetech, Inc.
Decision Date2006-08-04
Product CodeCEM
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

OSMETECH OPTI R CRITICAL CARE ANALYZER, MODEL GD7044 is the device name listed in this FDA 510(k) record. The listed applicant is Osmetech, Inc.. It received FDA 510(k) clearance on 2006-08-04 under 510(k) number K061730. 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 OSMETECH OPTI R CRITICAL CARE ANALYZER, MODEL GD7044?

OSMETECH OPTI R CRITICAL CARE ANALYZER, MODEL GD7044 is a medical device that received FDA 510(k) clearance on 2006-08-04. The listed applicant is Osmetech, Inc.. The 510(k) number is K061730.

When did OSMETECH OPTI R CRITICAL CARE ANALYZER, MODEL GD7044 receive FDA 510(k) clearance?

OSMETECH OPTI R CRITICAL CARE ANALYZER, MODEL GD7044 received FDA 510(k) clearance on 2006-08-04, under 510(k) number K061730.

Who is the listed applicant for OSMETECH OPTI R CRITICAL CARE ANALYZER, MODEL GD7044?

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

What is the FDA product code for OSMETECH OPTI R CRITICAL CARE ANALYZER, MODEL GD7044?

The FDA product code for OSMETECH OPTI R CRITICAL CARE ANALYZER, MODEL GD7044 is CEM.

Related Clinical Trials

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.

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Other records listing Osmetech, 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.

K052027OPTI LION ELECTROLYTE ANALYZER, MODEL GD7200

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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