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FDA 510(k)

I-STAT PORTABLE CLINICAL ANALYZER, MODEL 300

K-Number: K001387 · 2000-10-05

ApplicantI-Stat Corp.
Decision Date2000-10-05
Product CodeCGA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

I-STAT PORTABLE CLINICAL ANALYZER, MODEL 300 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 2000-10-05 under 510(k) number K001387. The device is classified under product code CGA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the I-STAT PORTABLE CLINICAL ANALYZER, MODEL 300?

I-STAT PORTABLE CLINICAL ANALYZER, MODEL 300 is a medical device that received FDA 510(k) clearance on 2000-10-05. The listed applicant is I-Stat Corp.. The 510(k) number is K001387.

When did I-STAT PORTABLE CLINICAL ANALYZER, MODEL 300 receive FDA 510(k) clearance?

I-STAT PORTABLE CLINICAL ANALYZER, MODEL 300 received FDA 510(k) clearance on 2000-10-05, under 510(k) number K001387.

Who is the listed applicant for I-STAT PORTABLE CLINICAL ANALYZER, MODEL 300?

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 PORTABLE CLINICAL ANALYZER, MODEL 300?

The FDA product code for I-STAT PORTABLE CLINICAL ANALYZER, MODEL 300 is CGA.

Related Clinical Trials

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.

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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 SYSTEMK001154I-STAT MODEL 200 PORTABLE CLINICAL ANALYZERK992571I-STAT SYSTEMK982071I-STAT LACTATE TESTK973292I-STAT SYSTEM

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Related Devices (Code: CGA)

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.

K252488ABL90 FLEX PLUS SystemRadiometer Medicals ApsK210933YSI 2900C Biochemistry AnalyzerYsi, Inc.K220328EasyStat 300Medica CorporationK223179Cholestech LDX ™ SystemAlere San Diego, Inc.K223755i-STAT G cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.K223710i-STAT CG8+ 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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