FDA 510(k)

ISE REAGENTS FOR OLYMPUS AU 800/AU5200 CHEMISTRY SYSTEMS

K-Number: K972004 · 1997-06-16

Decision Date1997-06-16

Product CodeCGZ

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

ISE REAGENTS FOR OLYMPUS AU 800/AU5200 CHEMISTRY SYSTEMS is the device name listed in this FDA 510(k) record. The listed applicant is Alko Diagnostic Corp.. It received FDA 510(k) clearance on 1997-06-16 under 510(k) number K972004. 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 ISE REAGENTS FOR OLYMPUS AU 800/AU5200 CHEMISTRY SYSTEMS?

ISE REAGENTS FOR OLYMPUS AU 800/AU5200 CHEMISTRY SYSTEMS is a medical device that received FDA 510(k) clearance on 1997-06-16. The listed applicant is Alko Diagnostic Corp.. The 510(k) number is K972004.

When did ISE REAGENTS FOR OLYMPUS AU 800/AU5200 CHEMISTRY SYSTEMS receive FDA 510(k) clearance?

ISE REAGENTS FOR OLYMPUS AU 800/AU5200 CHEMISTRY SYSTEMS received FDA 510(k) clearance on 1997-06-16, under 510(k) number K972004.

Who is the listed applicant for ISE REAGENTS FOR OLYMPUS AU 800/AU5200 CHEMISTRY SYSTEMS?

The FDA 510(k) record lists Alko Diagnostic Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ISE REAGENTS FOR OLYMPUS AU 800/AU5200 CHEMISTRY SYSTEMS?

The FDA product code for ISE REAGENTS FOR OLYMPUS AU 800/AU5200 CHEMISTRY SYSTEMS is CGZ.

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Other records listing Alko Diagnostic Corp. as applicant

K001484CALIBRATION SOLUTION 1, MODEL A943-837; CALIBRATION SOLUTION 2, MODEL A943-839; RINSE SOLUTION KIT, MODEL A943-838 K982501ELECTROLYTE BUFFER A443-325, ELECTROLYTE REFERENCE REAGENT A443-315, CO2 ACID REAGENT A443-330, CO2 ALKALINE BUFFER A44 K970921STANDARD A MULTIPLY (A540-0), STANDARD B MULTIPLY (A550-0), STANDARD C MULTIPLY (A560-0)K962864THB CAL STANDARD FOR IL CO-OXIMETERS/OXIMETERS K963734ISE REAGENTS FOR HITACHI 700 SERIES AND 911 CLINICAL CHEMISTRY SYSTEMS K960085ISE CALIBRANT A & B, ISE LIQUID REAGENT FOR PARAMAX CLINAK SYSTEMS

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Related Devices (Code: CGZ)

K182072VITROS Chemistry Products Cl-Slides, VITROS Chemistry Products ECO2 Slides, VITROS Chemistry Products GLU SlidesOrtho-Clinical Diagnostics, Inc.K170320Alinity c ICT Sample DiluentAbbott Laboratories K162020VITROS Chemistry Products Cl- SlidesOrtho Clinical Diagnostics K082099VITROS 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 OY K070531ISE MODULE AND BAR CODE READER ADDITION FOR THE DATAPRO CLINICAL CHEMISTRY ANALYZERThermo Fisher Scientific

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.