DCF — Albumin, Antigen, Antiserum, Control Class II
FDA Device Classification
Classification Details
- Product Code
- DCF
- Device Class
- Class II
- Regulation Number
- 866.5040
- Submission Type
- Review Panel
- IM
- Medical Specialty
- Immunology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K153560 | binding site group | Optilite Low Level Albumin Kit | August 25, 2016 |
| K143118 | binding site group | Human Microalbumin kit for use on SPAPLUS | May 26, 2015 |
| K142346 | beckman coulter ireland | Urine/CSF Albumin, Urine/CSF Albumin Calibrator | October 15, 2014 |
| K121045 | binding site group | HUMAN ALBUMIN CSF KIT | June 19, 2013 |
| K113072 | roche diagnostics operations | TINA-QUANT ALBUMIN GEN.2 | May 14, 2012 |
| K101089 | medica | EASYRA MICRO-ALBUMIN REAGENT AND CALIBRATOR | July 13, 2011 |
| K101203 | roche diagnostics | TINA-QUANT ALBUMIN GEN 2 | September 10, 2010 |
| K100853 | roche diagnostics | COBAS 8000 MODULAR SERIES ANALYZER | September 9, 2010 |
| K091486 | kamiya biomedical | K-ASSAY MICROALBUMIN AND K-ASSAY MICROALBUMIN CALIBRATOR | April 29, 2010 |
| K082251 | beckman coulter | SYNCHRON SYSTEMS MICROALBUMIN (MA) REAGENT, MODEL 475100 | April 8, 2009 |
| K061990 | dade behring | DIMENSION VISTA MICROALBUMIN FLEX REAGENT CARTRIDGE; PROTEIN 3 CALIBRATOR; PROTE | September 19, 2006 |
| K053553 | polymedco | NYCOCARD U-ALBUMIN AND U-ALBUMIN CONTROL | March 9, 2006 |
| K051191 | diagnostic chemicals | DCL MICROALBUMIN ASSAY, MODEL 252-20 | July 5, 2005 |
| K042643 | ortho-clinical diagnostics | VITROS CHEMISTRY PRODUCT MALB REAGENT, CALIBRATOR KIT 24, MALB PERFORMANCE VERIF | November 18, 2004 |
| K033525 | dade behring | DIMENSION MICROALBUMIN (MALB) FLEX REAGENT CARTRIDGE METHOD, CALIBRATOR, MODELS | January 12, 2004 |
| K972929 | behring diagnostics | N ANTISERUM TO HUMAN ALBUMIN | October 20, 1997 |
| K964695 | beckman instruments | IMMAGE IMMUNOCHEMISTRY SYSTEM ALBUMIN (ALB) REAGENT | April 29, 1997 |
| K961824 | roche diagnostic systems | COBAS INTEGRA REAGENT CASSETTES FOR ALBUMIN, HBALC AND DIGOXIN | July 23, 1996 |
| K953927 | international enzymes | LINICAL PROTEIN VI CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN ARRAY PROTEIN SY | September 15, 1995 |
| K914391 | binding site | ALBUMIN TEST RID KIT | December 10, 1991 |