Creatine Kinase MB Determination (UV)
FDA 510(k) K942958 · Biochemical Trade, Inc.
510(k) numberK942958
Submission
- Device name
- Creatine Kinase MB Determination (UV)
- Applicant
- Biochemical Trade, Inc.
Miami, FL, US - Received
- June 23, 1994
- Decision date
- November 21, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
| 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 |
| K935924 | Axsym Ck-MbJHW · Traditional | Abbott Laboratories | 06/21/1994SE |
| K931050 | Cardio Rep CK Isoenzyme Kit - 3310JHW · Traditional | Helena Laboratories | 04/20/1993SE |
More from Helena Laboratories
| 510(k) | Device | Decision |
|---|---|---|
| K910635 | Total Bilirubin Reagent SetCIG · Traditional | 05/15/1991SE |
| K910296 | Phosphorus (Inorganic) Test SystemCEO · Traditional | 02/27/1991SE |
| K905776 | Albumin Reagent SetCJW · Traditional | 02/26/1991SE |
| K905790 | Total Protein Reagent SetCEK · Traditional | 02/21/1991SE |
| K905650 | Kinetic Alkaline Phosphatase DeterminationCJE · Traditional | 02/13/1991SE |
| K905619 | Creatinine (Rate) Reagent SetCGX · Traditional | 02/13/1991SE |
| K905651 | Kinetic Amylase DeterminationJFJ · Traditional | 01/31/1991SE |
| K905649 | Gamma-Glutamyl Transferase DeterminationJQB · Traditional | 01/30/1991SE |
| K905588 | Creatine Kinase UV Reagent SetJHW · Traditional | 01/17/1991SE |
| K871547 | Ultra-Violet Bun Reagent Kit (Rate)CDQ · Traditional | 06/22/1987SE |
Questions and answers
When was Creatine Kinase MB Determination (UV) cleared by the FDA?
Creatine Kinase MB Determination (UV) (K942958) received a 510(k) decision of Substantially Equivalent on November 21, 1994, 151 days after the submission was received.
What is the product code of K942958?
The FDA product code is JHW – U.V. Method, Cpk Isoenzymes, a Class II (moderate risk) device regulated under 21 CFR 862.1215.