I-Stat Lactate Test
FDA 510(k) K982071 · I-Stat Corp.
510(k) numberK982071
Submission
- Device name
- I-Stat Lactate Test
- Applicant
- I-Stat Corp.
Princeton, NJ, US - Received
- June 12, 1998
- Decision date
- June 29, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KHP – Acid, Lactic, Enzymatic Method
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1450
- Specialty
- Clinical Chemistry
Other 510(k)s with product code KHP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K130113 | Piccolo Lactate Test SystemKHP · Traditional | Abaxis, Inc. | 03/11/2013SE |
| K113216 | Rapidpoint 500 Blood Gas AnalyerKHP · Traditional | Siemens Healthcare Diagnostics | 05/03/2012SE |
| K112955 | Nova Statstrip Lactate Hospital Meter SystemKHP · Traditional | Nova Biomedical Corporation | 01/05/2012SE |
| K112430 | I-Stat Lactate Test/I-Sat CG4+CARTRIDGEKHP · Traditional | Abbott Pont of Care, Inc. | 12/20/2011SE |
| K100602 | Nova Statstrip Lactate Hospital Meter, Nova Statstrip Lactate Test StripsKHP · Traditional | Nova Biomedical Corp. | 08/17/2011SE |
| K093297 | Epoc Bgem, Epoc Reader, Epoc Host, Epoc Care-Fill Capillary TubeKHP · Traditional | Epocal, Inc. | 06/09/2010SE |
| K013938 | Irma SL Blood Analysis System Lactate CartridgeKHP · Traditional | Diametrics Medical, Inc. | 01/28/2002SE |
| K011478 | I-Stat SystemKHP · Traditional | I-Stat Corp. | 07/02/2001SE |
| K980908 | Lactate Pro SystemKHP · Traditional | Kdk Corp. | 09/11/1998SE |
| K971944 | Lactest IKHP · Traditional | Jwt, Inc. | 12/17/1997SE |
More from Jwt, Inc.
| 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 I-Stat Lactate Test cleared by the FDA?
I-Stat Lactate Test (K982071) received a 510(k) decision of Substantially Equivalent on June 29, 1998, 17 days after the submission was received.
What is the product code of K982071?
The FDA product code is KHP – Acid, Lactic, Enzymatic Method, a Class I (low risk) device regulated under 21 CFR 862.1450.