I-Stat Portable Clinical Analyzer, Model 300
FDA 510(k) K001387 · I-Stat Corp.
510(k) numberK001387
Submission
- Device name
- I-Stat Portable Clinical Analyzer, Model 300
- Applicant
- I-Stat Corp.
East Windsor, NJ, US - Received
- May 2, 2000
- Decision date
- October 5, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CGA – Glucose Oxidase, Glucose
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1345
- Specialty
- Clinical Chemistry
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| K223090 | GEM Premier ChemSTATCGA · Special | Instrumentation Laboratory CO | 01/27/2023SE |
| K203549 | Nova Primary Glucose Analyzer SystemCGA · Traditional | Nova Biomedical Corporation | 10/18/2022SE |
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| K200349 | Stat Profile Prime Plus Analyzer SystemCGA · Traditional | Nova Biomedical Corporation | 03/13/2020SE |
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| K053597 | I-Stat B-Type Natriuretic Peptide (BNP)NBC · Traditional | 07/21/2006SE |
| K053110 | Abbott i-STAT Crea Cartridge, Abbott i-STAT G Cartridge, Abbott i-STAT 6+ Cartridge…JGS · Special | 01/13/2006SE |
| K051433 | I-Stat Creatine Kinase MB (Ck-Mb)MYT · Traditional | 12/15/2005SE |
| K031873 | I-Stat Cardiac Markers Control Level 1, 2, and 3; Cardiac Markers Calibration…JJX · Traditional | 10/07/2003SE |
| K023582 | I-Stat Kaolin Act TestJBP · Traditional | 09/08/2003SE |
| K031739 | I-Stat Cardiac Troponin (Ctni) TestMMI · Traditional | 09/02/2003SE |
| K020355 | I-Stat Prothrombin Time TestGJS · Traditional | 05/14/2002SE |
| K012478 | Modification to: I-Stat Portable Clinical AnalyzerCHL · Special | 08/20/2001SE |
| K011478 | I-Stat SystemKHP · Traditional | 07/02/2001SE |
| K001154 | I-Stat Model 200 Portable Clinical AnalyzerJGS · Special | 04/18/2000SE |
Questions and answers
When was I-Stat Portable Clinical Analyzer, Model 300 cleared by the FDA?
I-Stat Portable Clinical Analyzer, Model 300 (K001387) received a 510(k) decision of Substantially Equivalent on October 5, 2000, 156 days after the submission was received.
What is the product code of K001387?
The FDA product code is CGA – Glucose Oxidase, Glucose, a Class II (moderate risk) device regulated under 21 CFR 862.1345.