Liquispex(Tm) Liquid B2M Control Level 1 and 2
FDA 510(k) K946048 · Clinical Controls, Inc.
510(k) numberK946048
Submission
- Device name
- Liquispex(Tm) Liquid B2M Control Level 1 and 2
- Applicant
- Clinical Controls, Inc.
Grover Beach, CA, US - Received
- December 12, 1994
- Decision date
- February 10, 1995
- 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 |
|---|---|---|
| K012907 | Liquispx Liquid Saliva or Unrine Drug of Abuse ControlDIF · Traditional | 09/28/2001SE |
| K964278 | Whole Blood Glucose Control Level 1,2,AND 3/WHOLE Blood Glucose Linearity…JJX · Traditional | 11/22/1996SE |
| K962432 | Liquispex Urine (Micro)Albumin ControlJJX · Traditional | 07/05/1996SE |
| K955691 | Serum Volatiles Control Level 1 & 2JJY · Traditional | 04/24/1996SE |
| K955690 | Aqueous Ethanol/Ammonia Control Level 1, 2, & 3JJY · Traditional | 04/24/1996SE |
| K946265 | Fibrinogen High Abnormal Control - Level 3GIL · Traditional | 08/24/1995SE |
| K935598 | Plasma Fibrinogen Control Level 1/LEVEL 2GIL · Traditional | 05/02/1995SE |
| K946266 | Ferritin Control - Level 1, 2, 3DGD · Traditional | 02/10/1995SE |
| K946050 | Liquispex(Tm) Liquid CRP Control Level 1 and 2DCK · Traditional | 02/10/1995SE |
| K946049 | Liquispex(Tm) Liquid B2M/CRP Control Level 1 and 2JJY · Traditional | 02/10/1995SE |
Questions and answers
When was Liquispex(Tm) Liquid B2M Control Level 1 and 2 cleared by the FDA?
Liquispex(Tm) Liquid B2M Control Level 1 and 2 (K946048) received a 510(k) decision of Substantially Equivalent on February 10, 1995, 60 days after the submission was received.
What is the product code of K946048?
The FDA product code is JZG – System, Test, Beta-2-Microglobulin Immunological, a Class II (moderate risk) device regulated under 21 CFR 866.5630.