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FDA 510(k)

ELECTRODE, ION SPECIFIC

K-Number: K915675 · 1992-04-29

ApplicantAlko Diagnostic Corp.
Decision Date1992-04-29
Product CodeJFP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ELECTRODE, ION SPECIFIC 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 1992-04-29 under 510(k) number K915675. The device is classified under product code JFP. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ELECTRODE, ION SPECIFIC?

ELECTRODE, ION SPECIFIC is a medical device that received FDA 510(k) clearance on 1992-04-29. The listed applicant is Alko Diagnostic Corp.. The 510(k) number is K915675.

When did ELECTRODE, ION SPECIFIC receive FDA 510(k) clearance?

ELECTRODE, ION SPECIFIC received FDA 510(k) clearance on 1992-04-29, under 510(k) number K915675.

Who is the listed applicant for ELECTRODE, ION SPECIFIC?

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 ELECTRODE, ION SPECIFIC?

The FDA product code for ELECTRODE, ION SPECIFIC is JFP.

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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: JFP)

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.

K230300i-STAT CG8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.K191360i-STAT CHEM8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.K191626Stat Profile Prime ES Comp Plus Analyzer SystemNova Biomedical CorporationK152327EasyLyte Na/K/Cl/Ca AnalyzerMedica CorporationK984299AVL OPTI CRITICAL CARE ANALYZERAvl Scientific Corp.K972673AVL 9181 ELECTROLYTE ANALYZERAvl Scientific Corp.

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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