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FDA 510(k)

STAT PROFILE 4 ANALYZER + QUALITY CONTROL MATERIAL

K-Number: K864445 · 1987-02-04

ApplicantNova Biomedical Corp.
Decision Date1987-02-04
Product CodeCHL
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

STAT PROFILE 4 ANALYZER + QUALITY CONTROL MATERIAL 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 1987-02-04 under 510(k) number K864445. 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 STAT PROFILE 4 ANALYZER + QUALITY CONTROL MATERIAL?

STAT PROFILE 4 ANALYZER + QUALITY CONTROL MATERIAL is a medical device that received FDA 510(k) clearance on 1987-02-04. The listed applicant is Nova Biomedical Corp.. The 510(k) number is K864445.

When did STAT PROFILE 4 ANALYZER + QUALITY CONTROL MATERIAL receive FDA 510(k) clearance?

STAT PROFILE 4 ANALYZER + QUALITY CONTROL MATERIAL received FDA 510(k) clearance on 1987-02-04, under 510(k) number K864445.

Who is the listed applicant for STAT PROFILE 4 ANALYZER + QUALITY CONTROL MATERIAL?

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 4 ANALYZER + QUALITY CONTROL MATERIAL?

The FDA product code for STAT PROFILE 4 ANALYZER + QUALITY CONTROL MATERIAL 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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