I-Stat Corp.

Also registered as I-Stat Corporation

Country not established

Devices: 21

Catalogue21

Newest first, rows 1-21 of 21

Search and filter all 21 devices

Modification To: I-Stat Portable Clinical Analyzer Ref K012478

Class II

Active 510(k) 510(k) II
Model 100 Portable Clinical Analyzer And Test Pack Ref K894914

Class II

Active 510(k) 510(k) II
I-Stat Control Levels 1, 2, 3 Ref K934641

Class I

Active 510(k) 510(k) I
I-Stat Tests For Acid-Base Parameters Ref K936081

Class II

Active 510(k) 510(k) II
I-Stat B-Type Natriuretic Peptide (Bnp) Ref K053597

Class II

Active 510(k) 510(k) II
I-Stat 200 Portable Clinical Analyzer Ref K940918 Open recall

Class II

Active 510(k) 510(k) II
I-Stat Cardiac Markers Control Level 1, 2, And 3; Cardiac Markers Calibration Verification Control Set Ref K031873

Class I

Active 510(k) 510(k) I
I-Stat System Ref K973292

Class II

Active 510(k) 510(k) II
I-Stat Portable Clinical Analyzer, Model 300 Ref K001387

Class II

Active 510(k) 510(k) II
Abbott i-STAT Crea Cartridge, Abbott i-STAT G Cartridge, Abbott i-STAT 6+ Cartridge, Abbott i-STAT EC4+ Cartridge, Abbott i-STAT E3+ Cartridge Ref K053110 Open recall

Class II

Active 510(k) 510(k) II
I-Stat(Tm) Levels 1, 2, 3 Controls Ref K921477

Class I

Active 510(k) 510(k) I
I-Stat Kaolin Act Test Ref K023582

Class II

Active 510(k) 510(k) II
I-Stat Cardiac Troponin (Ctni) Test Ref K031739

Class II

Active 510(k) 510(k) II
I-Stat Model 200 Portable Clinical Analyzer Ref K001154

Class II

Active 510(k) 510(k) II
I-Stat System Ref K992571

Class II

Active 510(k) 510(k) II
I-Stat Lactate Test Ref K982071 Open recall

Class I

Active 510(k) 510(k) I
I-Stat Model 100 Port Clin Analyzer & Test Pack Ref K912387

Class II

Active 510(k) 510(k) II
I-Stat Creatine Kinase Mb (Ck-Mb) Ref K051433

Class II

Active 510(k) 510(k) II
I-Stat Ionized Calcium Test Ref K934642

Class II

Active 510(k) 510(k) II
I-Stat Prothrombin Time Test Ref K020355

Class II

Active 510(k) 510(k) II
I-Stat System Ref K011478

Class I

Active 510(k) 510(k) I

Rows 1-21 of 21

Frequently asked questions

How many devices does I-Stat Corp. have in the registry?

The registry currently lists 21 devices for I-Stat Corp.. Devices recorded under merged duplicate company entries are counted once.

Which registries list I-Stat Corp.'s devices?

Among its 21 most recently registered devices, I-Stat Corp. has devices listed in FDA 510(k) (21 devices).

What risk classes do I-Stat Corp.'s devices fall under?

Among its 21 most recently registered devices, the classes recorded for I-Stat Corp.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

What are the newest devices from I-Stat Corp. in the registry?

The most recently registered devices listed for I-Stat Corp. include MODIFICATION TO: I-STAT PORTABLE CLINICAL ANALYZER, MODEL 100 PORTABLE CLINICAL ANALYZER AND TEST PACK, I-STAT CONTROL LEVELS 1, 2, 3 and I-STAT TESTS FOR ACID-BASE PARAMETERS.

Generated automatically from registry data and not verified by a human reviewer.

Catalogue21

Modification To: I-Stat Portable Clinical Analyzer Ref K012478

Model 100 Portable Clinical Analyzer And Test Pack Ref K894914

I-Stat Control Levels 1, 2, 3 Ref K934641

I-Stat Tests For Acid-Base Parameters Ref K936081

I-Stat B-Type Natriuretic Peptide (Bnp) Ref K053597

I-Stat 200 Portable Clinical Analyzer Ref K940918 Open recall

I-Stat Cardiac Markers Control Level 1, 2, And 3; Cardiac Markers Calibration Verification Control Set Ref K031873

I-Stat System Ref K973292

I-Stat Portable Clinical Analyzer, Model 300 Ref K001387

Abbott i-STAT Crea Cartridge, Abbott i-STAT G Cartridge, Abbott i-STAT 6+ Cartridge, Abbott i-STAT EC4+ Cartridge, Abbott i-STAT E3+ Cartridge Ref K053110 Open recall

I-Stat(Tm) Levels 1, 2, 3 Controls Ref K921477

I-Stat Kaolin Act Test Ref K023582

I-Stat Cardiac Troponin (Ctni) Test Ref K031739

I-Stat Model 200 Portable Clinical Analyzer Ref K001154

I-Stat System Ref K992571

I-Stat Lactate Test Ref K982071 Open recall

I-Stat Model 100 Port Clin Analyzer & Test Pack Ref K912387

I-Stat Creatine Kinase Mb (Ck-Mb) Ref K051433

I-Stat Ionized Calcium Test Ref K934642

I-Stat Prothrombin Time Test Ref K020355

I-Stat System Ref K011478

Frequently asked questions