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FDA 510(k)

SODIUM/POTASSIUM/IONIZED CALCIUM ANALYZ

K-Number: K823389 · 1983-02-02

ApplicantNova Biomedical Corp.
Decision Date1983-02-02
Product CodeJFP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SODIUM/POTASSIUM/IONIZED CALCIUM ANALYZ is the device name listed in this FDA 510(k) record. The listed applicant is Nova Biomedical Corp.. It received FDA 510(k) clearance on 1983-02-02 under 510(k) number K823389. 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 SODIUM/POTASSIUM/IONIZED CALCIUM ANALYZ?

SODIUM/POTASSIUM/IONIZED CALCIUM ANALYZ is a medical device that received FDA 510(k) clearance on 1983-02-02. The listed applicant is Nova Biomedical Corp.. The 510(k) number is K823389.

When did SODIUM/POTASSIUM/IONIZED CALCIUM ANALYZ receive FDA 510(k) clearance?

SODIUM/POTASSIUM/IONIZED CALCIUM ANALYZ received FDA 510(k) clearance on 1983-02-02, under 510(k) number K823389.

Who is the listed applicant for SODIUM/POTASSIUM/IONIZED CALCIUM ANALYZ?

The FDA 510(k) record lists Nova Biomedical Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SODIUM/POTASSIUM/IONIZED CALCIUM ANALYZ?

The FDA product code for SODIUM/POTASSIUM/IONIZED CALCIUM ANALYZ is JFP.

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Other records listing Nova Biomedical Corp. as applicant

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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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