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FDA 510(k)

REAGENTS FOR HITACHI ISE

K-Number: K933383 · 1994-03-09

ApplicantAlko Diagnostic Corp.
Decision Date1994-03-09
Product CodeJIX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

REAGENTS FOR HITACHI ISE 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 1994-03-09 under 510(k) number K933383. 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 HITACHI ISE?

REAGENTS FOR HITACHI ISE is a medical device that received FDA 510(k) clearance on 1994-03-09. The listed applicant is Alko Diagnostic Corp.. The 510(k) number is K933383.

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

REAGENTS FOR HITACHI ISE received FDA 510(k) clearance on 1994-03-09, under 510(k) number K933383.

Who is the listed applicant for REAGENTS FOR HITACHI ISE?

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 HITACHI ISE?

The FDA product code for REAGENTS FOR HITACHI ISE is JIX.

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Other records listing Alko Diagnostic Corp. 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.

K001484CALIBRATION SOLUTION 1, MODEL A943-837; CALIBRATION SOLUTION 2, MODEL A943-839; RINSE SOLUTION KIT, MODEL A943-838K982501ELECTROLYTE BUFFER A443-325, ELECTROLYTE REFERENCE REAGENT A443-315, CO2 ACID REAGENT A443-330, CO2 ALKALINE BUFFER A44K972004ISE REAGENTS FOR OLYMPUS AU 800/AU5200 CHEMISTRY SYSTEMSK970921STANDARD A MULTIPLY (A540-0), STANDARD B MULTIPLY (A550-0), STANDARD C MULTIPLY (A560-0)K962864THB CAL STANDARD FOR IL CO-OXIMETERS/OXIMETERSK963734ISE REAGENTS FOR HITACHI 700 SERIES AND 911 CLINICAL CHEMISTRY SYSTEMS

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Related Devices (Code: JIX)

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.

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 DiagnosticsK130765ELITECH CLINICAL SYSTEMS ELICAL 2; ELITECH CLINICAL SYSTEMS ELITROL I, ELITECH CLINICAL SYSTEMS ELITROL IIElitechgroupK123321DIMENSION CHEMISTRY III CALIBRATORYSiemens Healthcare DiagnosticsK123372ABBOTT LIPID MULTI CONSTITUENT CALIBRATORAbbott LaboratoriesK122398RAPIDPOINT 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.

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