Quantia BETA-2 Microglobulin, Model: 302822307
FDA 510(k) K072078 · Biokit, S.A.
510(k) numberK072078
Submission
- Device name
- Quantia BETA-2 Microglobulin, Model: 302822307
- Applicant
- Biokit, S.A.
Barcelona, ES - Received
- July 30, 2007
- Decision date
- December 19, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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
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|---|---|---|---|
| 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 |
| 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 |
| K002731 | N Latex B2-MICROGLOBULINJZG · Traditional | Dade Behring, Inc. | 11/20/2000SE |
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Questions and answers
When was Quantia BETA-2 Microglobulin, Model: 302822307 cleared by the FDA?
Quantia BETA-2 Microglobulin, Model: 302822307 (K072078) received a 510(k) decision of Substantially Equivalent on December 19, 2007, 142 days after the submission was received.
What is the product code of K072078?
The FDA product code is JZG – System, Test, Beta-2-Microglobulin Immunological, a Class II (moderate risk) device regulated under 21 CFR 866.5630.