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FDA 510(k)

I-STAT SYSTEM

K-Number: K973292 · 1997-10-20

ApplicantI-Stat Corp.
Decision Date1997-10-20
Product CodeCGL
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

I-STAT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is I-Stat Corp.. It received FDA 510(k) clearance on 1997-10-20 under 510(k) number K973292. The device is classified under product code CGL. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the I-STAT SYSTEM?

I-STAT SYSTEM is a medical device that received FDA 510(k) clearance on 1997-10-20. The listed applicant is I-Stat Corp.. The 510(k) number is K973292.

When did I-STAT SYSTEM receive FDA 510(k) clearance?

I-STAT SYSTEM received FDA 510(k) clearance on 1997-10-20, under 510(k) number K973292.

Who is the listed applicant for I-STAT SYSTEM?

The FDA 510(k) record lists I-Stat Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for I-STAT SYSTEM?

The FDA product code for I-STAT SYSTEM is CGL.

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Other records listing I-Stat 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.

K012478MODIFICATION TO: I-STAT PORTABLE CLINICAL ANALYZERK011478I-STAT SYSTEMK001387I-STAT PORTABLE CLINICAL ANALYZER, MODEL 300K001154I-STAT MODEL 200 PORTABLE CLINICAL ANALYZERK992571I-STAT SYSTEMK982071I-STAT LACTATE TEST

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Related Devices (Code: CGL)

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.

K261039i-STAT Crea cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.K171059Nova StatSensor Creatinine Hospital Meter SystemNova Biomedical CorporationK113726EPOC CHLORIDE TEST AND EPOC CREATININE TESTEpocal, Inc.K070068NOVA STATSENSOR CREATININE HOSPITAL METER, CONTROL SOLUTIONS,LINEARITY SOLUTIONS, AND TEST STRIPSNova Biomedical Corp.K051968ABL8X7 FLEXRadiometer Medical ApsK991727STAT PROFILE M7 ANALYZERNova Biomedical 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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