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FDA 510(k)

NOVA 16 ANALYZER (MODIFICATION POINT OF CARE USAGE)

K-Number: K963005 · 1996-08-23

ApplicantNova Biomedical Corp.
Decision Date1996-08-23
Product CodeJFL
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

NOVA 16 ANALYZER (MODIFICATION POINT OF CARE USAGE) 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 1996-08-23 under 510(k) number K963005. The device is classified under product code JFL. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NOVA 16 ANALYZER (MODIFICATION POINT OF CARE USAGE)?

NOVA 16 ANALYZER (MODIFICATION POINT OF CARE USAGE) is a medical device that received FDA 510(k) clearance on 1996-08-23. The listed applicant is Nova Biomedical Corp.. The 510(k) number is K963005.

When did NOVA 16 ANALYZER (MODIFICATION POINT OF CARE USAGE) receive FDA 510(k) clearance?

NOVA 16 ANALYZER (MODIFICATION POINT OF CARE USAGE) received FDA 510(k) clearance on 1996-08-23, under 510(k) number K963005.

Who is the listed applicant for NOVA 16 ANALYZER (MODIFICATION POINT OF CARE USAGE)?

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 16 ANALYZER (MODIFICATION POINT OF CARE USAGE)?

The FDA product code for NOVA 16 ANALYZER (MODIFICATION POINT OF CARE USAGE) is JFL.

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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: JFL)

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.

K191298i-STAT CHEM8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.K040975GENCHEM CO2 ACID REAGENTGenchem, Inc.K014034MODIFICATION TO SYNCHRON LX CLINICAL CHEMISTRY SYSTEMS (LX20 AND LX20 PRO)Beckman Coulter, Inc.K963541SIGMA DIAGNOSTICS CO2 ACID REAGENTSigma Diagnostics, Inc.K963538SIGMA DIAGNOSTICS CO2ALKALINE BUFFERSigma Diagnostics, Inc.K963540SIGMA DIAGNOSTICS ELECTROLYTE BUFFERSigma 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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