BETA-2 Microglobulin Eia
FDA 510(k) K901333 · Serex, Inc.
510(k) numberK901333
Submission
- Device name
- BETA-2 Microglobulin Eia
- Applicant
- Serex, Inc.
Tenafly, NJ, US - Received
- March 20, 1990
- Decision date
- April 2, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|
| K923314 | Automates Coma Plus Cocaine Metabolite AssayJXO · Traditional | 08/24/1992SE |
| K921834 | Automates Coma Cocaine Metabolite AssayDIO · Traditional | 06/15/1992SE |
| K895043 | Coma Cocaine Metabolite Assay (Eia)DIO · Traditional | 11/08/1989SE |
| K890694 | BETA-2 Microglobulin EiaJZG · Traditional | 03/16/1989SE |
Questions and answers
When was BETA-2 Microglobulin Eia cleared by the FDA?
BETA-2 Microglobulin Eia (K901333) received a 510(k) decision of Substantially Equivalent on April 2, 1990, 13 days after the submission was received.
What is the product code of K901333?
The FDA product code is JZG – System, Test, Beta-2-Microglobulin Immunological, a Class II (moderate risk) device regulated under 21 CFR 866.5630.