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FDA 510(k)

STAT PROFILE ULTRA F,G,H,I,J,K, AND L ANALYZERS

K-Number: K981426 · 1998-05-12

ApplicantNova Biomedical Corp.
Decision Date1998-05-12
Product CodeGKF
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

STAT PROFILE ULTRA F,G,H,I,J,K, AND L ANALYZERS 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 1998-05-12 under 510(k) number K981426. The device is classified under product code GKF. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STAT PROFILE ULTRA F,G,H,I,J,K, AND L ANALYZERS?

STAT PROFILE ULTRA F,G,H,I,J,K, AND L ANALYZERS is a medical device that received FDA 510(k) clearance on 1998-05-12. The listed applicant is Nova Biomedical Corp.. The 510(k) number is K981426.

When did STAT PROFILE ULTRA F,G,H,I,J,K, AND L ANALYZERS receive FDA 510(k) clearance?

STAT PROFILE ULTRA F,G,H,I,J,K, AND L ANALYZERS received FDA 510(k) clearance on 1998-05-12, under 510(k) number K981426.

Who is the listed applicant for STAT PROFILE ULTRA F,G,H,I,J,K, AND L ANALYZERS?

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 STAT PROFILE ULTRA F,G,H,I,J,K, AND L ANALYZERS?

The FDA product code for STAT PROFILE ULTRA F,G,H,I,J,K, AND L ANALYZERS is GKF.

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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: GKF)

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.

K160415GEM Premier 5000 (Measured parameters: Hematocrit, Total Hemoglobin, Carboxyhemoglobin, Methemoglobin, Deoxyhemoglobin, Oxyhemoglobin, Oxygen Saturation)Instrumentation Laboratory COK983551CRIT-SCAN II MONITORIn-Line Diagnostics Corp.K981425STAT PROFILE ULTRA A, B, C, D, AND E ANALYZERSNova Biomedical Corp.K981427STAT PROFILE M ANALYZERNova Biomedical Corp.K953519MICROSPIN 24Vulcon TechnologiesK915825MARATHON 6K GENERAL-PURPOSE CENTRIFUGEFisher Scientific Co., LLC

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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