Chemmate(Tm) UCHL1 (CD45-RO)
FDA 510(k) K950152 · Biotek Solutions, Inc.
510(k) numberK950152
Submission
- Device name
- Chemmate(Tm) UCHL1 (CD45-RO)
- Applicant
- Biotek Solutions, Inc.
Santa Barbara, CA, US - Received
- January 17, 1995
- Decision date
- October 27, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DFH – Kappa, Antigen, Antiserum, Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5550
- Specialty
- Immunology
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| K211648 | Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain AssayDFH · Traditional | Diazyme Laboratories, Inc. | 09/08/2022SE |
| K220001 | Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain AssayDFH · Traditional | Diazyme Laboratories, Inc. | 08/04/2022SE |
| K212379 | N Latex FLC kappa, N Latex FLC lambdaDFH · Traditional | Siemens Healthcare Diagnostics Products GmbH | 03/02/2022SE |
| K201496 | N Latex FLC kappa, N Latex FLC lambdaDFH · Traditional | Siemens Healthcare Diagnostics Products GmbH | 10/29/2021SE |
| K193047 | N Latex FLC kappa, N Latex FLC lambdaDFH · Traditional | Siemens Healthcare Diagnostics Products GmbH | 07/14/2021SE |
More from Siemens Healthcare Diagnostics Products GmbH
| 510(k) | Device | Decision |
|---|---|---|
| K950148 | Chemmate(Tm) CD43DEH · Traditional | 07/02/1996SE |
| K936111 | Chemmate Special Stain LCA-CD45DEH · Traditional | 02/27/1996SE |
| K950149 | Chemmate(Tm) LambdaDEH · Traditional | 12/06/1995SE |
| 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) UCHL1 (CD45-RO) cleared by the FDA?
Chemmate(Tm) UCHL1 (CD45-RO) (K950152) received a 510(k) decision of Substantially Equivalent on October 27, 1995, 283 days after the submission was received.
What is the product code of K950152?
The FDA product code is DFH – Kappa, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5550.