DSL Active BETA2-MICROGLOBULIN (DSL 6500)
FDA 510(k) K915508 · Diagnostic Systems Laboratories, Inc.
510(k) numberK915508
Submission
- Device name
- DSL Active BETA2-MICROGLOBULIN (DSL 6500)
- Applicant
- Diagnostic Systems Laboratories, Inc.
Webster, TX, US - Received
- December 9, 1991
- Decision date
- March 17, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- JZG – System, Test, Beta-2-Microglobulin Immunological
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5630
- Specialty
- Immunology
Other 510(k)s with product code JZG
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K161297 | Beta-2-MicroglobulinJZG · Special | Beckman Coulter Ireland, Inc. | 06/07/2016SE |
| K122066 | Human BETA-2 Microglobulin Urine Kit for Use on the SpaplusJZG · Special | The Binding Site Group , Ltd. | 08/30/2012SE |
| K110874 | Advia Chemistry Reagents, and Advia Chemistry B2-MICROGLOBULIN CalibratorJZG · Traditional | Siemens Healthcare Diagnostics, Inc. | 01/20/2012SE |
| K083289 | Human BETA-2 Microglobulin KitJZG · Traditional | The Binding Site, Ltd. | 05/06/2009SE |
| K083463 | Dimension Vista Beta 2 Microglobulin, Dimension Vista Protein 1 Calibrator, Dimension…JZG · Traditional | Siemens Healthcare Diagnostics | 03/13/2009SE |
| K072078 | Quantia BETA-2 Microglobulin, Model: 302822307JZG · Traditional | Biokit, S.A. | 12/19/2007SE |
| K063272 | Dimension Vista B2MIC Flex Reagent Cartridge, Protein 1 Calibrator, Control Medium…JZG · Traditional | Dade Behring, Inc. | 01/26/2007SE |
| K050613 | Quantia BETA-2 MicroglobulinJZG · Traditional | Biokit, S.A. | 08/16/2005SE |
| K032692 | Dakocytomation BETA-2-MICROGLOBULIN Kit, Code No. Oa 368JZG · Traditional | Dako A/S | 01/22/2004SE |
| K014270 | Minineph Human B2-MICROGLOBULIN KitJZG · Traditional | The Binding Site, Ltd. | 08/15/2002SE |
More from The Binding Site, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K061758 | Active Renin IrmaCIB · Special | 07/28/2006SE |
| K020945 | Axsym Intact PTH, Model 2G06CEW · Traditional | 05/31/2002SE |
| K020128 | Active Free Beta-Hcg Elisa, Model DSL-10-8500JHI · Traditional | 03/01/2002SE |
| K002128 | Active Inhibin-A Elisa, Model DSL-10-28100NDR · Traditional | 12/05/2000SE |
| K001086 | Free Testosterone Enzyme Immunoassay, Model DSL-10-4900CDZ · Traditional | 05/18/2000SE |
| K990138 | DSL Active Afp Elisa, Model DSL-10-8400LOJ · Traditional | 06/21/1999SE |
| K981871 | C-Reactive Protein Elisa, Model Number DSL-10-42100DCK · Traditional | 11/09/1998SE |
| K973244 | Active Psa Irma (DSL-9700)LTJ · Traditional | 08/03/1998SE |
| K973243 | Active Psa Elisa (DSL-10-9700)LTJ · Traditional | 08/03/1998SE |
| K981607 | Active Renin Irma Model Number DSL-25100CIB · Traditional | 05/27/1998SE |
Questions and answers
When was DSL Active BETA2-MICROGLOBULIN (DSL 6500) cleared by the FDA?
DSL Active BETA2-MICROGLOBULIN (DSL 6500) (K915508) received a 510(k) decision of Substantially Equivalent on March 17, 1992, 99 days after the submission was received.
What is the product code of K915508?
The FDA product code is JZG – System, Test, Beta-2-Microglobulin Immunological, a Class II (moderate risk) device regulated under 21 CFR 866.5630.