Creatine Phosphokinase (CPK) Reagent Set
FDA 510(k) K792533 · Macomb Chemical Co.
510(k) numberK792533
Submission
- Device name
- Creatine Phosphokinase (CPK) Reagent Set
- Applicant
- Macomb Chemical Co.
Mchenry, IL, US - Received
- December 7, 1979
- Decision date
- January 11, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
| K122083 | Elitech Clinical Systems CK Nac SLJHW · Traditional | Elitechgroup | 08/22/2012SE |
| 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 |
More from Abbott Laboratories
| 510(k) | Device | Decision |
|---|---|---|
| K830095 | Rapid Chem Analyzer IIJJF · Traditional | 01/28/1983SE |
| K823720 | SpectrophotometerJJQ · Traditional | 01/07/1983SE |
| K810958 | GlycohemoglobinLCP · Traditional | 09/16/1981SE |
| K801086 | P-Nitrophenyl Phosphate · Traditional | 05/28/1980SE |
| K800719 | Enzymatic Urea Nitrogen Reagent Set ReviCDQ · Traditional | 05/08/1980SE |
| K800720 | Macomb Nad-Nicotinamide Adenine Dinucleo · Traditional | 04/21/1980SE |
| K792532 | Glucose (Hexokinase) Reagent SetCFR · Traditional | 01/11/1980SE |
| K791669 | Glucose Oxidase Reagent SetCGA · Traditional | 09/24/1979SE |
| K791511 | Enzymatic Reagent Set, 4X250 Ml.CHH · Traditional | 09/04/1979SE |
| K791119 | Macomb Normal Control SerumJJY · Traditional | 07/30/1979SE |
Questions and answers
When was Creatine Phosphokinase (CPK) Reagent Set cleared by the FDA?
Creatine Phosphokinase (CPK) Reagent Set (K792533) received a 510(k) decision of Substantially Equivalent on January 11, 1980, 35 days after the submission was received.
What is the product code of K792533?
The FDA product code is JHW – U.V. Method, Cpk Isoenzymes, a Class II (moderate risk) device regulated under 21 CFR 862.1215.