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FDA 510(k)

OPTI LION ELECTROLYTE ANALYZER, MODEL GD7200

K-Number: K052027 · 2005-09-29

ApplicantOsmetech, Inc.
Decision Date2005-09-29
Product CodeCGZ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

OPTI LION ELECTROLYTE ANALYZER, MODEL GD7200 is the device name listed in this FDA 510(k) record. The listed applicant is Osmetech, Inc.. It received FDA 510(k) clearance on 2005-09-29 under 510(k) number K052027. The device is classified under product code CGZ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OPTI LION ELECTROLYTE ANALYZER, MODEL GD7200?

OPTI LION ELECTROLYTE ANALYZER, MODEL GD7200 is a medical device that received FDA 510(k) clearance on 2005-09-29. The listed applicant is Osmetech, Inc.. The 510(k) number is K052027.

When did OPTI LION ELECTROLYTE ANALYZER, MODEL GD7200 receive FDA 510(k) clearance?

OPTI LION ELECTROLYTE ANALYZER, MODEL GD7200 received FDA 510(k) clearance on 2005-09-29, under 510(k) number K052027.

Who is the listed applicant for OPTI LION ELECTROLYTE ANALYZER, MODEL GD7200?

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 OPTI LION ELECTROLYTE ANALYZER, MODEL GD7200?

The FDA product code for OPTI LION ELECTROLYTE ANALYZER, MODEL GD7200 is CGZ.

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.

K061730OSMETECH OPTI R CRITICAL CARE ANALYZER, MODEL GD7044

Related Devices (Code: CGZ)

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.

K182072VITROS Chemistry Products Cl-Slides, VITROS Chemistry Products ECO2 Slides, VITROS Chemistry Products GLU SlidesOrtho-Clinical Diagnostics, Inc.K170320Alinity c ICT Sample DiluentAbbott LaboratoriesK162020VITROS Chemistry Products Cl- SlidesOrtho Clinical DiagnosticsK082099VITROS CHEMISTRY PRODUCTS CI-DT SLIDES; VITROS CHEMISTRY PRODUCTS DT CALIBRATOR KIT, MODELS CI-DT SLIDES:131 4905Ortho-Clinical Diagnostics, Inc.K070889AUTODELFIA NEONATAL IRT L KIT, MODEL B022-112Wallac OYK070531ISE MODULE AND BAR CODE READER ADDITION FOR THE DATAPRO CLINICAL CHEMISTRY ANALYZERThermo Fisher Scientific

Official Source

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