I-Stat Control Levels 1,2,3
FDA 510(k) K934641 · I-Stat Corp.
510(k) numberK934641
Submission
- Device name
- I-Stat Control Levels 1,2,3
- Applicant
- I-Stat Corp.
Princeton, NJ, US - Received
- September 21, 1993
- Decision date
- December 9, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- JJR – Electrolyte Controls (Assayed And Unassayed)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1660
- Specialty
- Clinical Chemistry
Other 510(k)s with product code JJR
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K990971 | Easylyte Quality Control Kit, Models 2814, 2815, 2816JJR · Traditional | Medica Corp. | 04/27/1999SE |
| K960592 | Electrolyte StandardsJJR · Traditional | Phoenix Diagnostics, Inc. | 05/13/1996SE |
| K955630 | RNA Medical Hemat ControlJJR · Traditional | Bionostics, Inc. | 03/01/1996SE |
| K951435 | Aalto Scientific Sweat Chloride Reference MaterialJJR · Traditional | Aalto Scientific, Ltd. | 05/02/1995SE |
| K943925 | Sweat Controls for Cystic Fibrosis TestingJJR · Traditional | Quantimetrix Corp. | 10/04/1994SE |
| K912513 | Electrolyte ControlJJR · Traditional | Verichem Laboratories, Inc. | 07/19/1991SE |
| K902266 | Electrolyte Controls (Assayed and Unassayed)JJR · Traditional | Phoenix Diagnostics, Inc. | 06/06/1990SE |
| K894576 | Ciba Corning Certain LyteJJR · Traditional | Ciba Corning Diagnostics Corp. | 10/30/1989SE |
| K895582 | Qclyte Protein-Based Ise ControlJJR · Traditional | Baxter Healthcare Corp | 10/04/1989SE |
| K881773 | Document(Tm) Direct Ise Linearity Test SetJJR · Traditional | Casco Standards | 06/10/1988SE |
More from Casco Standards
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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 |
| K001387 | I-Stat Portable Clinical Analyzer, Model 300CGA · Traditional | 10/05/2000SE |
Questions and answers
When was I-Stat Control Levels 1,2,3 cleared by the FDA?
I-Stat Control Levels 1,2,3 (K934641) received a 510(k) decision of Substantially Equivalent on December 9, 1993, 79 days after the submission was received.
What is the product code of K934641?
The FDA product code is JJR – Electrolyte Controls (Assayed And Unassayed), a Class I (low risk) device regulated under 21 CFR 862.1660.