Ck-Mb Method for the Technicon Immuno 1(R) System In-Vitro Diagnostic System
FDA 510(k) K950186 · Miles, Inc.
510(k) numberK950186
Submission
- Device name
- Ck-Mb Method for the Technicon Immuno 1(R) System In-Vitro Diagnostic System
- Applicant
- Miles, Inc.
Tarrytown, NY, US - Received
- January 17, 1995
- Decision date
- March 13, 1995
- 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 |
| 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 |
| 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 |
More from Helena Laboratories
| 510(k) | Device | Decision |
|---|---|---|
| K950292 | Folate Assay for the Technicon Immuno 1 System, in Vitro Diagnostic SystemCGN · Traditional | 05/02/1995SE |
| K950353 | Technicon Immuno 1(R) System In-Vitro Diagnostic SystemJJE · Traditional | 04/20/1995SE |
| K945655 | Creatinine (Enzymatic UV) Procedure for Technicon Systems (in Vitro Diagnostic Test…CGX · Traditional | 01/05/1995SE |
| K941171 | Technicon H* 3 RTC System (In-Vitro Diagnostic System)GKZ · Traditional | 12/14/1994SE |
| K943376 | Opera SystemJJC · Traditional | 09/14/1994SE |
| K941156 | Technison Axon SystemKHS · Traditional | 04/26/1994SE |
| K933682 | Direct Amylase (Ec 3.2.1.1) Method for Technicon SystemsJFJ · Traditional | 04/12/1994SE |
| K935287 | Iron -Ii (Fe-Ii) Method/Tech Chem 1(R) 1+TM SystemJIY · Traditional | 01/03/1994SE |
| K933478 | Technicon H*1 Systems, Labfacts Software for U.I.W. Versions 4.11 & 5.11GKZ · Traditional | 11/22/1993SE |
| K933475 | Technicon H* 2 System, Labfacts Software for U.I.W. Versions 4.11 & 5.11GKZ · Traditional | 11/22/1993SE |
Questions and answers
When was Ck-Mb Method for the Technicon Immuno 1(R) System In-Vitro Diagnostic System cleared by the FDA?
Ck-Mb Method for the Technicon Immuno 1(R) System In-Vitro Diagnostic System (K950186) received a 510(k) decision of Substantially Equivalent on March 13, 1995, 55 days after the submission was received.
What is the product code of K950186?
The FDA product code is JHW – U.V. Method, Cpk Isoenzymes, a Class II (moderate risk) device regulated under 21 CFR 862.1215.