Coulter Ck-Mb Isoenzyme Reagent
FDA 510(k) K904866 · Coulter Electronics, Inc.
510(k) numberK904866
Submission
- Device name
- Coulter Ck-Mb Isoenzyme Reagent
- Applicant
- Coulter Electronics, Inc.
Hialeah, FL, US - Received
- October 29, 1990
- Decision date
- December 13, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JHT – Chromatographic Separation, Cpk Isoenzymes
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1215
- Specialty
- Clinical Chemistry
Other 510(k)s with product code JHT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K022409 | Spectral's Cardiac Status Ck-Mb Rapid TestJHT · Traditional | Spectral Diagnostics, Inc. | 09/30/2002SE |
| K991299 | Modification to Cardiac Status Ck-Mb/Myoglobin Rapid One-Step Test, Lifesign Mi…JHT · Traditional | Princeton BioMeditech Corp. | 05/28/1999SE |
| K930359 | Cardio Rep-Cat. No. 1400 & CK Isoforms Kit 3305JHT · Traditional | Helena Laboratories | 04/12/1993SE |
| K904721 | DSL Ck-Mb (DSL #3200)JHT · Traditional | Diagnostic Systems Laboratories, Inc. | 12/13/1990SE |
| K901450 | Modified Label for Embria-Ck, Quick-Mb/Micromi-MbJHT · Traditional | Intl. Immunoassay Laboratories, Inc. | 05/15/1990SE |
| K896170 | Rep CK Isoforms Kit Cat. No. 3081, 3082, 3083JHT · Traditional | Helena Laboratories | 02/16/1990SE |
| K881168 | Creatine Kinase (CK) Isoenzyme MBJHT · Traditional | Data Medical Associates, Inc. | 11/10/1988SE |
| K874284 | Shot-Gun Isolat Proced/Measurement Ck-Mb in SerumJHT · Traditional | Diagnostic Chemicals, Ltd. (Usa) | 01/21/1988SE |
| K872041 | Coulter Dart Ck-Mb Isoenzyme Reagent SystemJHT · Traditional | Coulter Electronics, Inc. | 09/16/1987SE |
| K872598 | Micromi-Ck(Tm)JHT · Traditional | Intl. Immunoassay Laboratories, Inc. | 08/03/1987SE |
More from Intl. Immunoassay Laboratories, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K923951 | CD8 Cytospheres KitMAM · Traditional | 04/25/1994SE |
| K930119 | Coulter Retic-C Cell ControlJPK · Traditional | 04/05/1993SE |
| K921279 | CD4 Cytospheres KitGKZ · Traditional | 12/29/1992SE |
| K923530 | Coulter Multi-Q-PrepGKH · Traditional | 10/14/1992SE |
| K922181 | Coulter MH009GKZ · Traditional | 08/17/1992SE |
| K922704 | Coulter Maxm W/ AutoloaderGKZ · Traditional | 07/27/1992SE |
| K921567 | Coulter MH017GKZ · Traditional | 07/06/1992SE |
| K912133 | PX Coulter(R) Cell ControlJPK · Traditional | 07/17/1991SE |
| K911385 | Coulter(R) MH010GKZ · Traditional | 06/17/1991SE |
| K905771 | Coulter Dart Ast (Got) ReagentCIT · Traditional | 02/26/1991SE |
Questions and answers
When was Coulter Ck-Mb Isoenzyme Reagent cleared by the FDA?
Coulter Ck-Mb Isoenzyme Reagent (K904866) received a 510(k) decision of Substantially Equivalent on December 13, 1990, 45 days after the submission was received.
What is the product code of K904866?
The FDA product code is JHT – Chromatographic Separation, Cpk Isoenzymes, a Class II (moderate risk) device regulated under 21 CFR 862.1215.