CD8 Cytospheres Kit
FDA 510(k) K923951 · Coulter Electronics, Inc.
510(k) numberK923951
Submission
- Device name
- CD8 Cytospheres Kit
- Applicant
- Coulter Electronics, Inc.
Hialeah, FL, US - Received
- August 6, 1992
- Decision date
- April 25, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MAM – Dna-Probe, B And T Lymphocyte
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.5220
- Specialty
- Hematology
More from Coulter Electronics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| 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 |
| K905767 | Coulter Dart Alt (GPT) ReagentCKA · Traditional | 01/25/1991SE |
Questions and answers
When was CD8 Cytospheres Kit cleared by the FDA?
CD8 Cytospheres Kit (K923951) received a 510(k) decision of Substantially Equivalent on April 25, 1994, 627 days after the submission was received.
What is the product code of K923951?
The FDA product code is MAM – Dna-Probe, B And T Lymphocyte, a Class II (moderate risk) device regulated under 21 CFR 864.5220.