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FDA 510(k)

NOVA 8 IONIZED CALCIUM/PH ANALYZER

K-Number: K830502 · 1983-03-24

ApplicantNova Biomedical Corp.
Decision Date1983-03-24
Product CodeJFP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

NOVA 8 IONIZED CALCIUM/PH ANALYZER 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 1983-03-24 under 510(k) number K830502. 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 NOVA 8 IONIZED CALCIUM/PH ANALYZER?

NOVA 8 IONIZED CALCIUM/PH ANALYZER is a medical device that received FDA 510(k) clearance on 1983-03-24. The listed applicant is Nova Biomedical Corp.. The 510(k) number is K830502.

When did NOVA 8 IONIZED CALCIUM/PH ANALYZER receive FDA 510(k) clearance?

NOVA 8 IONIZED CALCIUM/PH ANALYZER received FDA 510(k) clearance on 1983-03-24, under 510(k) number K830502.

Who is the listed applicant for NOVA 8 IONIZED CALCIUM/PH ANALYZER?

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 NOVA 8 IONIZED CALCIUM/PH ANALYZER?

The FDA product code for NOVA 8 IONIZED CALCIUM/PH ANALYZER is JFP.

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Other records listing Nova Biomedical 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.

K100602NOVA STATSTRIP LACTATE HOSPITAL METER, NOVA STATSTRIP LACTATE TEST STRIPSK101633NOVA MAX PLUS GLOCOSE AND B-KETONE CONTROL SOLUTION-MID, HIGHK091547NOVA MAX PLUS BLOOD GLUCOSE AND B-KETONE MONITOR SYSTEM, NOVA MAX PLUS B-KETONE CONTROL SOLUTIONS, NOVA MAX BLOOD GLUCOSK070960NOVA STATSTRIP XPRESS GLUCOSE HOSPITAL METER SYSTEMK070255NOVA MAX BLOOD GLUCOSE MONITOR SYSTEM, 90001,90002K070068NOVA STATSENSOR CREATININE HOSPITAL METER, CONTROL SOLUTIONS,LINEARITY SOLUTIONS, AND TEST STRIPS

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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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