Beckman Ma Microalbumin Reagent Kit
FDA 510(k) K895883 · Beckman Instruments, Inc.
510(k) numberK895883
Submission
- Device name
- Beckman Ma Microalbumin Reagent Kit
- Applicant
- Beckman Instruments, Inc.
Brea, CA, US - Received
- October 5, 1989
- Decision date
- December 27, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JIQ – Turbidimetric Method, Protein Or Albumin (Urinary, Non-Quant.)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1645
- Specialty
- Clinical Chemistry
Other 510(k)s with product code JIQ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K141925 | Total Protein Urine/Csf GEN.3JIQ · Special | Roche Diagnostics Operations (Rdo) | 12/09/2014SE |
| K013643 | Ausam Total Albumin AssayJIQ · Traditional | Ausam Biotecthnologies, Inc. | 08/14/2003SE |
| K991800 | Hemochek Urine Collection KitJIQ · Traditional | Osborn Group, Inc. | 09/24/1999SE |
| K971458 | Enzip Immunoturbidimetric Microalbumin Assay KitJIQ · Traditional | Diagnostic Specialties | 09/02/1997SE |
| K965035 | Immage Immunochemistry System Microalbumin (Ma) ReagentJIQ · Traditional | Beckman Instruments, Inc. | 04/17/1997SE |
| K944664 | Wako Micro-Albumin B/Wako Micro Albumin CalibratorJIQ · Traditional | Wako Chemicals USA, Inc. | 02/07/1995SE |
| K936202 | Urinary Albumin Test PackJIQ · Traditional | Dupont Medical Products | 05/09/1994SE |
| K935662 | Synermed Ir 500 Chemistry AnalyzerJIQ · Traditional | Synermed, Inc. | 04/26/1994SE |
| K903123 | Raichem(Tm) Spia(Tm) Microalbulmin ReagentJIQ · Traditional | Reagents Applications, Inc. | 09/14/1990SE |
| K902216 | Wako(Tm) Micro-AlbuminJIQ · Traditional | Wako Chemicals USA, Inc. | 06/18/1990SE |
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| 510(k) | Device | Decision |
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| K973448 | Access Toxoplasma Igm Reagents on the Access Immunoassay Analyzer, Models 34460, 34465…LGD · Traditional | 09/17/1998SE |
| K982250 | Access Free T4 Reagents on the Access Immunoassay AnalyzerCEC · Traditional | 07/14/1998SE |
| K981403 | Immage Immunochemistry System Valproic Acid (Vpa) ReagentDKB · Traditional | 05/08/1998SE |
| K981354 | Access Afp Reagents on the Access Immunoassay Analyzer Model Number 33211LOJ · Traditional | 05/01/1998SE |
| K980173 | Access Total BHCG Reagents on the Access Immunoassay Analyzer; 33500, 33505JHI · Traditional | 03/18/1998SE |
| K974816 | Access(R) Psa Reagents on the Access(R) Immunoassay Analyzer 33220, 33225, 33229LTJ · Traditional | 02/20/1998SE |
| K974564 | Immage Immunochemistry System ALPHA-2-MACROGLOBULIN ReagentDEB · Traditional | 02/17/1998SE |
| K974110 | Immage Immunochemistry System Antithrombin III (AT3) ReagentJBQ · Traditional | 12/24/1997SE |
| K974452 | Vigil Lipid ControlJJY · Traditional | 12/17/1997SE |
| K973932 | Beckman Calibrator 2 (CAL2)JIX · Traditional | 12/15/1997SE |
Questions and answers
When was Beckman Ma Microalbumin Reagent Kit cleared by the FDA?
Beckman Ma Microalbumin Reagent Kit (K895883) received a 510(k) decision of Substantially Equivalent on December 27, 1989, 83 days after the submission was received.
What is the product code of K895883?
The FDA product code is JIQ – Turbidimetric Method, Protein Or Albumin (Urinary, Non-Quant.), a Class I (low risk) device regulated under 21 CFR 862.1645.