FDA Product Code
FDA Product Code DCF — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Immunology
- 21 CFR Citation
- 866.5040
510(k) Clearances — 37 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K153560 | Optilite Low Level Albumin Kit | The Binding Site Group , Ltd. | 2016-08-25 | Traditional | PDF ↗ |
| K143118 | Human Microalbumin kit for use on SPAPLUS | The Binding Site Group , Ltd. | 2015-05-26 | Traditional | PDF ↗ |
| K142346 | Urine/CSF Albumin, Urine/CSF Albumin Calibrator | Beckman Coulter Ireland, Inc. | 2014-10-15 | Traditional | PDF ↗ |
| K121045 | HUMAN ALBUMIN CSF KIT | The Binding Site Group , Ltd. | 2013-06-19 | Traditional | PDF ↗ |
| K113072 | TINA-QUANT ALBUMIN GEN.2 | Roche Diagnostics Operations | 2012-05-14 | Traditional | PDF ↗ |
| K101089 | EASYRA MICRO-ALBUMIN REAGENT AND CALIBRATOR | Medica Corp. | 2011-07-13 | Traditional | PDF ↗ |
| K101203 | TINA-QUANT ALBUMIN GEN 2 | Roche Diagnostics | 2010-09-10 | Traditional | PDF ↗ |
| K100853 | COBAS 8000 MODULAR SERIES ANALYZER | Roche Diagnostics Corp. | 2010-09-09 | Special | PDF ↗ |
| K091486 | K-ASSAY MICROALBUMIN AND K-ASSAY MICROALBUMIN CALIBRATOR | Kamiya Biomedical Co. | 2010-04-29 | Traditional | PDF ↗ |
| K082251 | SYNCHRON SYSTEMS MICROALBUMIN (MA) REAGENT, MODEL 475100 | Beckman Coulter, Inc. | 2009-04-08 | Traditional | PDF ↗ |
| K061990 | DIMENSION VISTA MICROALBUMIN FLEX REAGENT CARTRIDGE; PROTEIN 3 CALIBRATOR; PROTEIN 3 CONTROL | Dade Behring, Inc. | 2006-09-19 | Traditional | PDF ↗ |
| K053553 | NYCOCARD U-ALBUMIN AND U-ALBUMIN CONTROL | Polymedco, Inc. | 2006-03-09 | Traditional | PDF ↗ |
| K051191 | DCL MICROALBUMIN ASSAY, MODEL 252-20 | Diagnostic Chemicals , Ltd. | 2005-07-05 | Traditional | PDF ↗ |
| K042643 | VITROS CHEMISTRY PRODUCT MALB REAGENT, CALIBRATOR KIT 24, MALB PERFORMANCE VERIFIERS I AND II | Ortho-Clinical Diagnostics, Inc. | 2004-11-18 | Traditional | PDF ↗ |
| K033525 | DIMENSION MICROALBUMIN (MALB) FLEX REAGENT CARTRIDGE METHOD, CALIBRATOR, MODELS DF114, DC114 | Dade Behring, Inc. | 2004-01-12 | Traditional | PDF ↗ |
| K972929 | N ANTISERUM TO HUMAN ALBUMIN | Behring Diagnostics, Inc. | 1997-10-20 | Traditional | PDF ↗ |
| K964695 | IMMAGE IMMUNOCHEMISTRY SYSTEM ALBUMIN (ALB) REAGENT | Beckman Instruments, Inc. | 1997-04-29 | Traditional | PDF ↗ |
| K961824 | COBAS INTEGRA REAGENT CASSETTES FOR ALBUMIN, HBALC AND DIGOXIN | Roche Diagnostic Systems, Inc. | 1996-07-23 | Traditional | PDF ↗ |
| K953927 | LINICAL PROTEIN VI CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN ARRAY PROTEIN SYSTEM | International Enzymes, Inc. | 1995-09-15 | Traditional | PDF ↗ |
| K914391 | ALBUMIN TEST RID KIT | The Binding Site, Ltd. | 1991-12-10 | Traditional | PDF ↗ |
| K900167 | TURBIQUANT IMMUNOGLOBULIN & ALBUMIN KIT | Behring Diagnostics, Inc. | 1990-01-22 | Traditional | PDF ↗ |
| K896059 | MODIFIED QM300 ALBUMIN ANTIBODY PACK | Kallestad Diag, A Div. of Erbamont, Inc. | 1989-11-06 | Traditional | PDF ↗ |
| K895808 | TECHNICON DPA-1(TM) SYSTEM SERUM ALBUMIN | Technicon Instruments Corp. | 1989-10-17 | Traditional | PDF ↗ |
| K882153 | TECHNICON DPA-1(TM) SYSTEM | Technicon Instruments Corp. | 1988-08-04 | Traditional | PDF ↗ |
| K882082 | QM300 ALBUMIN ANTIBODY PACK | Kallestad Diag, A Div. of Erbamont, Inc. | 1988-07-08 | Traditional | PDF ↗ |
| K881127 | QM300 CALIBRATOR D PACK | Kallestad Diag, A Div. of Erbamont, Inc. | 1988-04-21 | Traditional | PDF ↗ |
| K881126 | QM300 ALBUMIN ANTIBODY PACK | Kallestad Diag, A Div. of Erbamont, Inc. | 1988-04-06 | Traditional | PDF ↗ |
| K875161 | MAT (TM) MICROALBUMIN TEST | Wampole Laboratories | 1988-02-17 | Traditional | PDF ↗ |
| K873862 | ALBUMIN IN SERUM | Unipath , Ltd. | 1987-10-20 | Traditional | PDF ↗ |
| K873861 | ALBUMIN IN URINE | Unipath , Ltd. | 1987-10-13 | Traditional | PDF ↗ |
| K862671 | MICROALBUMINURIA ASSAY | Orion Corp. | 1986-09-18 | Traditional | PDF ↗ |
| K851285 | RADIAL IMMUNODIFFUSION PLATES CSF IGG & CSF ALBUMI | Cooper Biomedical, Inc. | 1985-06-17 | Traditional | PDF ↗ |
| K812496 | IMMUNOGL. FRCT. OF RABBIT ANTISER.-ALBUM | Dako Corp. | 1981-09-23 | Traditional | PDF ↗ |
| K802404 | ORTHO BOVINE ALBUMIN SOLUTION 30% PROTE | Ortho Diagnostics, Inc. | 1980-10-23 | Traditional | PDF ↗ |
| K780913 | ADDITIONAL REAGENTS KITS FOR IMM. SYSTEM | Beckman Instruments, Inc. | 1978-06-22 | Traditional | PDF ↗ |
| K771771 | QUAN. COLOR. DETER. OF SERUM ALBUMIN | Stanbio Laboratory | 1977-10-07 | Traditional | PDF ↗ |
| K761225 | LOW LEVEL HUMAN ALBUMIN TEST KITS | Intl. Diagnostic Technology | 1977-04-07 | Traditional | PDF ↗ |
Product code DCF · Class II · Immunology. Data: openFDA.