FDA 510(k)

REAGENTS FOR COBAS ISE MODULE

K-Number: K934701 · 1993-12-02

Decision Date1993-12-02

Product CodeJIX

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

REAGENTS FOR COBAS ISE MODULE 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 1993-12-02 under 510(k) number K934701. The device is classified under product code JIX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REAGENTS FOR COBAS ISE MODULE?

REAGENTS FOR COBAS ISE MODULE is a medical device that received FDA 510(k) clearance on 1993-12-02. The listed applicant is Alko Diagnostic Corp.. The 510(k) number is K934701.

When did REAGENTS FOR COBAS ISE MODULE receive FDA 510(k) clearance?

REAGENTS FOR COBAS ISE MODULE received FDA 510(k) clearance on 1993-12-02, under 510(k) number K934701.

Who is the listed applicant for REAGENTS FOR COBAS ISE MODULE?

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 REAGENTS FOR COBAS ISE MODULE?

The FDA product code for REAGENTS FOR COBAS ISE MODULE is JIX.

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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 K972004ISE REAGENTS FOR OLYMPUS AU 800/AU5200 CHEMISTRY SYSTEMS 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

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Related Devices (Code: JIX)

K161140VITROS Chemistry Products Calibrator Kit 3Ortho-Clinical Diagnostics, Inc.K133330C.F.A.S. PROTEINS, C.F.A.S. PAC, PRECICONTROL CLINCHEM MULTI 1 & 2, PRECINORM PROTEIN & PRECIPATH PROTEINRoche Diagnostics K130765ELITECH CLINICAL SYSTEMS ELICAL 2; ELITECH CLINICAL SYSTEMS ELITROL I, ELITECH CLINICAL SYSTEMS ELITROL IIElitechgroup K123321DIMENSION CHEMISTRY III CALIBRATORYSiemens Healthcare Diagnostics K123372ABBOTT LIPID MULTI CONSTITUENT CALIBRATORAbbott Laboratories K122398RAPIDPOINT 500 SYSTEM MEASUREMENT CARTRIDGE WITH CALIBRATORSSiemens Healthcare Diagnostics, Inc.

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.