Model 100 Portable Clinical Analyzer and Test Pack
FDA 510(k) K894914 · I-Stat Corp.
510(k) numberK894914
Submission
- Device name
- Model 100 Portable Clinical Analyzer and Test Pack
- Applicant
- I-Stat Corp.
Princeton, NJ, US - Received
- August 2, 1989
- Decision date
- October 16, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JGS – Electrode, Ion Specific, Sodium
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1665
- Specialty
- Clinical Chemistry
Other 510(k)s with product code JGS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252475 | ABL90 FLEX PLUS SystemJGS · Traditional | Radiometer Medicals Aps | 05/01/2026SE |
| K230275 | i-STAT CG8+ cartridge with the i-STAT 1 SystemJGS · Traditional | Abbott Point of Care, Inc. | 10/27/2023SE |
| K222438 | A-LYTE® Integrated Multisensor (IMT Na K Cl)JGS · Traditional | Siemens Healthcare Diagnostics, Inc. | 07/25/2023SE |
| K220977 | ISE Reagents, Glucose, CRP Latex, DxC 500 AU Clinical Chemistry AnalyzerJGS · Traditional | Beckman Coulter Laboratory Systems (Suzhou) Co.… | 07/20/2023SE |
| K213486 | GLP systems TrackJGS · Traditional | Abbott Laboratories | 03/10/2022SE |
| K200403 | Stat Profile Prime Plus Analyzer SystemJGS · Traditional | Nova Biomedical Corporation | 04/14/2020SE |
| K183688 | i-STAT CHEM8+ cartridge with the i-STAT 1 SystemJGS · Traditional | Abbott Point of Care, Inc. | 02/07/2020SE |
| K191365 | Stat Profile Prime ES Comp Plus Analyzer SystemJGS · Traditional | Nova Biomedical Corporation | 07/19/2019SE |
| K172232 | LIASYS 600 Electrolyte Measurement System, LIASYS 600 Creatinine reagent, LIASYS 600JGS · Traditional | Ams Diagnostics | 06/12/2019SE |
| K183549 | GEM Premier ChemSTATJGS · Traditional | Instrumentation Laboratory CO | 02/16/2019SE |
More from Instrumentation Laboratory CO
| 510(k) | Device | Decision |
|---|---|---|
| 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 |
| K001387 | I-Stat Portable Clinical Analyzer, Model 300CGA · Traditional | 10/05/2000SE |
Questions and answers
When was Model 100 Portable Clinical Analyzer and Test Pack cleared by the FDA?
Model 100 Portable Clinical Analyzer and Test Pack (K894914) received a 510(k) decision of Substantially Equivalent on October 16, 1989, 75 days after the submission was received.
What is the product code of K894914?
The FDA product code is JGS – Electrode, Ion Specific, Sodium, a Class II (moderate risk) device regulated under 21 CFR 862.1665.