FDA 510(k)

ELECTROLYTE BUFFER A443-325, ELECTROLYTE REFERENCE REAGENT A443-315, CO2 ACID REAGENT A443-330, CO2 ALKALINE BUFFER A44

K-Number: K982501 · 1998-09-01

Decision Date1998-09-01

Product CodeJIX

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

ELECTROLYTE BUFFER A443-325, ELECTROLYTE REFERENCE REAGENT A443-315, CO2 ACID REAGENT A443-330, CO2 ALKALINE BUFFER A44 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 1998-09-01 under 510(k) number K982501. 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 ELECTROLYTE BUFFER A443-325, ELECTROLYTE REFERENCE REAGENT A443-315, CO2 ACID REAGENT A443-330, CO2 ALKALINE BUFFER A44?

ELECTROLYTE BUFFER A443-325, ELECTROLYTE REFERENCE REAGENT A443-315, CO2 ACID REAGENT A443-330, CO2 ALKALINE BUFFER A44 is a medical device that received FDA 510(k) clearance on 1998-09-01. The listed applicant is Alko Diagnostic Corp.. The 510(k) number is K982501.

When did ELECTROLYTE BUFFER A443-325, ELECTROLYTE REFERENCE REAGENT A443-315, CO2 ACID REAGENT A443-330, CO2 ALKALINE BUFFER A44 receive FDA 510(k) clearance?

ELECTROLYTE BUFFER A443-325, ELECTROLYTE REFERENCE REAGENT A443-315, CO2 ACID REAGENT A443-330, CO2 ALKALINE BUFFER A44 received FDA 510(k) clearance on 1998-09-01, under 510(k) number K982501.

Who is the listed applicant for ELECTROLYTE BUFFER A443-325, ELECTROLYTE REFERENCE REAGENT A443-315, CO2 ACID REAGENT A443-330, CO2 ALKALINE BUFFER A44?

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 ELECTROLYTE BUFFER A443-325, ELECTROLYTE REFERENCE REAGENT A443-315, CO2 ACID REAGENT A443-330, CO2 ALKALINE BUFFER A44?

The FDA product code for ELECTROLYTE BUFFER A443-325, ELECTROLYTE REFERENCE REAGENT A443-315, CO2 ACID REAGENT A443-330, CO2 ALKALINE BUFFER A44 is JIX.

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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.