Chemmate(Tm) CD43
FDA 510(k) K950148 · Biotek Solutions, Inc.
510(k) numberK950148
Submission
- Device name
- Chemmate(Tm) CD43
- Applicant
- Biotek Solutions, Inc.
Santa Barbara, CA, US - Received
- January 17, 1995
- Decision date
- July 2, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DEH – Lambda, Antigen, Antiserum, Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5550
- Specialty
- Immunology
Other 510(k)s with product code DEH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K172471 | VENTANA CD30 (Ber-H2) RxDx AssayDEH · Traditional | Ventana Medical Systems, Inc. | 05/08/2018SE |
| K140396 | Freelite Human Lambda Free KitDEH · Traditional | The Binding Site Group , Ltd. | 04/16/2014SE |
| K083601 | Lambda Light ChainsDEH · Traditional | SENTINEL CH. SpA | 06/22/2009SE |
| K033811 | Freelite Human Kappa and Lambda Free Kits for Use on the Olympus Au AnalyzerDEH · Traditional | The Binding Site, Ltd. | 01/30/2004SE |
| K031016 | Freelite Human Kappa and Lambda Free Kits for Use on the Dad Behring Nephelometer IIDEH · Traditional | The Binding Site, Ltd. | 07/15/2003SE |
| K023131 | Freelite Human Lambda Free KitDEH · Traditional | The Binding Site, Ltd. | 01/21/2003SE |
| K010441 | Freelite Kappa Free KitDEH · Traditional | The Binding Site, Ltd. | 04/26/2001SE |
| K010440 | Freelite Lambda Free KitDEH · Traditional | The Binding Site, Ltd. | 04/26/2001SE |
| K003671 | Lambda Immage Freelite KitDEH · Traditional | The Binding Site, Ltd. | 02/01/2001SE |
| K002563 | Sheep Anti-Human Lambda Free Light Chain Immunofixation Grade KitDEH · Traditional | The Binding Site, Ltd. | 10/26/2000SE |
More from The Binding Site, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K936111 | Chemmate Special Stain LCA-CD45DEH · Traditional | 02/27/1996SE |
| K950149 | Chemmate(Tm) LambdaDEH · Traditional | 12/06/1995SE |
| K950152 | Chemmate(Tm) UCHL1 (CD45-RO)DFH · Traditional | 10/27/1995SE |
| K950150 | Chemmate(Tm) KappaDFH · Traditional | 10/27/1995SE |
| K950151 | Chemmate(Tm) L26 (CD20)DEH · Traditional | 10/04/1995SE |
Questions and answers
When was Chemmate(Tm) CD43 cleared by the FDA?
Chemmate(Tm) CD43 (K950148) received a 510(k) decision of Substantially Equivalent on July 2, 1996, 532 days after the submission was received.
What is the product code of K950148?
The FDA product code is DEH – Lambda, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5550.