FDA 510(k)

REAGENTS FOR ABBOTT SPECTRUM/EPX (ELECTRO CALIBRA)

K-Number: K925385 · 1994-01-13

Decision Date1994-01-13

Product CodeJIX

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

REAGENTS FOR ABBOTT SPECTRUM/EPX (ELECTRO CALIBRA) 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 1994-01-13 under 510(k) number K925385. 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 ABBOTT SPECTRUM/EPX (ELECTRO CALIBRA)?

REAGENTS FOR ABBOTT SPECTRUM/EPX (ELECTRO CALIBRA) is a medical device that received FDA 510(k) clearance on 1994-01-13. The listed applicant is Alko Diagnostic Corp.. The 510(k) number is K925385.

When did REAGENTS FOR ABBOTT SPECTRUM/EPX (ELECTRO CALIBRA) receive FDA 510(k) clearance?

REAGENTS FOR ABBOTT SPECTRUM/EPX (ELECTRO CALIBRA) received FDA 510(k) clearance on 1994-01-13, under 510(k) number K925385.

Who is the listed applicant for REAGENTS FOR ABBOTT SPECTRUM/EPX (ELECTRO CALIBRA)?

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 ABBOTT SPECTRUM/EPX (ELECTRO CALIBRA)?

The FDA product code for REAGENTS FOR ABBOTT SPECTRUM/EPX (ELECTRO CALIBRA) 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

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