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FDA 510(k)

ANALYZER: NOVA STAT PROFILE 1 QUA CON MAT: ELECT

K-Number: K852790 · 1985-11-12

ApplicantNova Biomedical Corp.
Decision Date1985-11-12
Product CodeCHL
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ANALYZER: NOVA STAT PROFILE 1 QUA CON MAT: ELECT 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 1985-11-12 under 510(k) number K852790. The device is classified under product code CHL. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ANALYZER: NOVA STAT PROFILE 1 QUA CON MAT: ELECT?

ANALYZER: NOVA STAT PROFILE 1 QUA CON MAT: ELECT is a medical device that received FDA 510(k) clearance on 1985-11-12. The listed applicant is Nova Biomedical Corp.. The 510(k) number is K852790.

When did ANALYZER: NOVA STAT PROFILE 1 QUA CON MAT: ELECT receive FDA 510(k) clearance?

ANALYZER: NOVA STAT PROFILE 1 QUA CON MAT: ELECT received FDA 510(k) clearance on 1985-11-12, under 510(k) number K852790.

Who is the listed applicant for ANALYZER: NOVA STAT PROFILE 1 QUA CON MAT: ELECT?

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 ANALYZER: NOVA STAT PROFILE 1 QUA CON MAT: ELECT?

The FDA product code for ANALYZER: NOVA STAT PROFILE 1 QUA CON MAT: ELECT is CHL.

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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: CHL)

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.

K252207ABL90 FLEX PLUS System, safeCLINITUBESRadiometer Medicals ApsK244014i-STAT CG4+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.K240998ABL90 FLEX PLUS SystemRadiometer Medicals ApsK230285i-STAT CG8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.K221900Stat Profile Prime Plus Analyzer SystemNova Biomedical CorporationK223857i-STAT G3+ cartridge with the i-STAT 1 SystemAbbott Point of Care, 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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