DCF — Albumin, Antigen, Antiserum, Control Class II
FDA product code DCF covers "Albumin, Antigen, Antiserum, Control", a Class II medical device regulated under 21 CFR 866.5040. Submissions are reviewed by the Immunology panel. At least 20 recent 510(k) clearances have been granted under this product code.
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 |