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FDA 510(k)

I-STAT KAOLIN ACT TEST

K-Number: K023582 · 2003-09-08

ApplicantI-Stat Corporation
Decision Date2003-09-08
Product CodeJBP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

I-STAT KAOLIN ACT TEST is the device name listed in this FDA 510(k) record. The listed applicant is I-Stat Corporation. It received FDA 510(k) clearance on 2003-09-08 under 510(k) number K023582. 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 KAOLIN ACT TEST?

I-STAT KAOLIN ACT TEST is a medical device that received FDA 510(k) clearance on 2003-09-08. The listed applicant is I-Stat Corporation. The 510(k) number is K023582.

When did I-STAT KAOLIN ACT TEST receive FDA 510(k) clearance?

I-STAT KAOLIN ACT TEST received FDA 510(k) clearance on 2003-09-08, under 510(k) number K023582.

Who is the listed applicant for I-STAT KAOLIN ACT TEST?

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

What is the FDA product code for I-STAT KAOLIN ACT TEST?

The FDA product code for I-STAT KAOLIN ACT TEST is JBP.

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Other records listing I-Stat Corporation 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.

K053597I-STAT B-TYPE NATRIURETIC PEPTIDE (BNP)K053110Abbott i-STAT Crea Cartridge, Abbott i-STAT G Cartridge, Abbott i-STAT 6+ Cartridge, Abbott i-STAT EC4+ Cartridge, Abbott i-STAT E3+ CartridgeK051433I-STAT CREATINE KINASE MB (CK-MB)K031873I-STAT CARDIAC MARKERS CONTROL LEVEL 1, 2, AND 3; CARDIAC MARKERS CALIBRATION VERIFICATION CONTROL SETK031739I-STAT CARDIAC TROPONIN (CTNI) TESTK020355I-STAT PROTHROMBIN TIME TEST

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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.K020914ACTALYKE XL ACTIVATED CLOTTING TIME ANALYZER, MODEL 5770Helena LaboratoriesK013078ACTALYKE MINI ACTIVATED CLOTTING TIME TEST SYSTEM, MODEL 5750/5752Helena LaboratoriesK002528SONOCLOT COAGULATION & PLATELET FUNCTION ANALYZER SYSTEM WITH SIGNATURE VIEWER OPTIONSienco, 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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