Elitech Clinical Systems CK Nac SL
FDA 510(k) K122083 · Elitechgroup
510(k) numberK122083
Submission
- Device name
- Elitech Clinical Systems CK Nac SL
- Applicant
- Elitechgroup
Bothell, WA, US - Received
- July 16, 2012
- Decision date
- August 22, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JHW – U.V. Method, Cpk Isoenzymes
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1215
- Specialty
- Clinical Chemistry
Other 510(k)s with product code JHW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K162526 | Creatine Kinase-MBJHW · Traditional | Roche Diagnostics | 05/26/2017SE |
| K141265 | Elitech Clinical Systems Envoy 500 CK Reagent KitJHW · Traditional | Elitechgroup | 07/18/2014SE |
| K023744 | Wiener Lab. Ck-Mb DS UV Unitest, Model 28 X 2.5 ML Cat. Nr. 1271354JHW · Traditional | Wiener Laboratories Saic | 01/03/2003SE |
| K003158 | Roche Diagnostics Ck-MbJHW · Traditional | Roche Diagnostics Corp. | 12/18/2000SE |
| K961501 | Elecsys Ck-MbJHW · Traditional | Boehringer Mannheim Corp. | 06/11/1996SE |
| K950186 | Ck-Mb Method for the Technicon Immuno 1(R) System In-Vitro Diagnostic SystemJHW · Traditional | Miles, Inc. | 03/13/1995SE |
| K944325 | Lifesign, Care Point, Vitalsign, AccusignJHW · Traditional | Princeton BioMeditech Corp. | 02/22/1995SE |
| K942958 | Creatine Kinase MB Determination (UV)JHW · Traditional | Biochemical Trade, Inc. | 11/21/1994SE |
| K935924 | Axsym Ck-MbJHW · Traditional | Abbott Laboratories | 06/21/1994SE |
| K931050 | Cardio Rep CK Isoenzyme Kit - 3310JHW · Traditional | Helena Laboratories | 04/20/1993SE |
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| K180627 | Macroduct Advanced Model 3710KTB · Traditional | 07/27/2018SE |
| K171401 | ELITech Clinical Systems BILIRUBIN TOTAL 4+1, ELITech Clinical Systems BILIRUBIN DIRECT…CIG · Traditional | 07/11/2017SE |
| K153644 | ELITech Clinical Systems GLUCOSE HK SL, ELITech Clinical Systems ELICAL 2, ELITech…CFR · Traditional | 09/07/2016SE |
| K151113 | ELITech Clinical Systems CALCIUM ARSENAZOCJY · Traditional | 07/22/2015SE |
| K151552 | ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I, ELITech Clinical…JIX · Abbreviated | 07/08/2015SE |
| K141265 | Elitech Clinical Systems Envoy 500 CK Reagent KitJHW · Traditional | 07/18/2014SE |
| K132399 | Elitech Clinical Systems Creatinine Pap SL, Elical 2, Elitrol I and Elitrol II, Urine…JFY · Traditional | 01/03/2014SE |
| K130765 | Elitech Clinical Systems Elical 2; Elitech Clinical Systems Elitrol I, Elitech Clinical…JIX · Abbreviated | 04/04/2013SE |
| K122177 | Elitech Clinical Systems Urine Total Protein Plus Standard 100 Mg/Dl, Elitech Clinical…JIT · Abbreviated | 02/15/2013SE |
Questions and answers
When was Elitech Clinical Systems CK Nac SL cleared by the FDA?
Elitech Clinical Systems CK Nac SL (K122083) received a 510(k) decision of Substantially Equivalent on August 22, 2012, 37 days after the submission was received.
What is the product code of K122083?
The FDA product code is JHW – U.V. Method, Cpk Isoenzymes, a Class II (moderate risk) device regulated under 21 CFR 862.1215.