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FDA 510(k)

I-STAT SYSTEM

K-Number: K992571 · 2000-02-10

ApplicantI-Stat Corp.
Decision Date2000-02-10
Product CodeJBP
Advisory CommitteeHE
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 2000-02-10 under 510(k) number K992571. The device is classified under product code JBP. It was reviewed by the HE 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 2000-02-10. The listed applicant is I-Stat Corp.. The 510(k) number is K992571.

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

I-STAT SYSTEM received FDA 510(k) clearance on 2000-02-10, under 510(k) number K992571.

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 JBP.

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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 ANALYZERK982071I-STAT LACTATE TESTK973292I-STAT SYSTEM

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Related Devices (Code: JBP)

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.

K223635Sonoclot Coagulation & Platelet Function Analyzer System with Sonoclot ViewerSienco, Inc.K062604RAPIDTEG TEG-ACT TESTHaemoscope Corp.K032952AIACT KITSienco, Inc.K023582I-STAT KAOLIN ACT TESTI-Stat CorporationK020914ACTALYKE XL ACTIVATED CLOTTING TIME ANALYZER, MODEL 5770Helena LaboratoriesK013078ACTALYKE MINI ACTIVATED CLOTTING TIME TEST SYSTEM, MODEL 5750/5752Helena Laboratories

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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