Product code CJW
- Device name
- Bromcresol Purple Dye-Binding, Albumin
- Medical specialty
- Clinical Chemistry
- Device class
- 2
- Regulation number
- 862.1035
- Review panel
- CH
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K203530 | Albumin BCP2 | Abbott Ireland Diagnostics Division | 2022-03-18 |
| K193001 | Albumin BCP | SENTINEL CH. SpA | 2019-12-19 |
| K132664 | ADVIA CHEMISTRY ALBUMIN BCP REAGENT (ALBP), ADVIA CHEMISTRY ALBUMIN BCP CALIBRATOR | Siemens Healthcare Diagnostics, Inc. | 2013-10-16 |
| K021636 | ALBUMIN REAGENT | Intersect Systems, Inc. | 2002-07-17 |
| K000483 | RANDOX ALBUMIN | Randox Laboratories, Ltd. | 2000-03-31 |
| K990978 | ALBUMIN BCG, MODEL AL 103-01 | A.P. Total Care, Inc. | 1999-05-25 |
| K981814 | ALBP | Abbott Laboratories | 1998-07-22 |
| K981457 | ALBP | Abbott Mfg., Inc. | 1998-05-27 |
| K913025 | ABBOTT QUICKSTART ALBUMIN BCP (ALBP)#5A16 | Em Diagnostic Systems, Inc. | 1991-10-09 |
| K905776 | ALBUMIN REAGENT SET | Biochemical Trade, Inc. | 1991-02-26 |
| K863226 | ALBUMIN (BCP) | Sigma Diagnostics, Inc. | 1986-09-17 |
| K863004 | EMDS(TM) ALBUMIN TESTPACKS, #67652/95 | Em Diagnostic Systems, Inc. | 1986-09-16 |
| K862138 | VISION ALBUMIN | Abbott Laboratories | 1986-06-17 |
| K860423 | A-GENT LIQUID ALBUMIN | Abbott Laboratories | 1986-03-17 |
| K844426 | ALBUMIN BCP | Boehringer Mannheim Corp. | 1985-01-07 |
| K842847 | WAKO AUTOMATED REAGENTS FOR HITACHI 705 | Wako Chemicals USA, Inc. | 1984-12-11 |
| K832632 | ALBUMIN PROCEDURE BCP | Sandare Chemical Co., Inc. | 1983-09-12 |
| K830934 | QUANTIMETRIX BROMERESOL PURPLE ALBUMIN | Quantimetrix Corp. | 1983-04-18 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00630414654003 | Atellica CH AlbP | Siemens Healthcare Diagnostics Inc. | 2026-03-18 |
| 00380740155490 | ARCHITECT | ABBOTT IRELAND | 2024-08-15 |
| 00380740155483 | ARCHITECT | ABBOTT IRELAND | 2024-08-15 |
| 00380740155292 | Alinity | ABBOTT IRELAND | 2024-08-15 |
| 00380740155285 | Alinity | ABBOTT IRELAND | 2024-08-15 |
| 08058056681980 | Albumin BCP (6x50 mL) | SENTINEL CH. SPA | 2020-02-24 |
| 08058056681973 | Albumin BCP (6x20 mL) | SENTINEL CH. SPA | 2020-02-24 |
| 00380740121723 | Alinity | Abbott GmbH | 2018-07-11 |
| 00630414595825 | Atellica CH AlbP | Siemens Healthcare Diagnostics Inc. | 2017-12-22 |
| 00630414947419 | ADVIA® Chemistry Albumin BCP Reagents | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00630414947402 | ADVIA® Chemistry Albumin BCP Reagents | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00842768015021 | Dimension Vista® Flex® reagent cartridge ALB | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00842768005343 | Dimension® Flex® reagent cartridge ALB | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| EABA40000371 | Piccolo MetLac 12 Panel | ABAXIS, INC. | 2016-09-23 |
| EABA40000031 | Piccolo Liver Panel Plus | ABAXIS, INC. | 2016-09-23 |
| EABA40000261 | Piccolo Hepatic Function Panel | ABAXIS, INC. | 2016-09-23 |
| EABA40000271 | Piccolo Renal Function Panel | ABAXIS, INC. | 2016-09-23 |
| EABA40000281 | Piccolo Comprehensive Metabolic Panel | ABAXIS, INC. | 2016-09-23 |
| EABA40000291 | Piccolo General Chemistry 13 | ABAXIS, INC. | 2016-09-23 |
| EABA40000351 | Piccolo BioChemistry Panel Plus | ABAXIS, INC. | 2016-09-23 |
| EABA40000411 | Piccolo AmLyte 13 | ABAXIS, INC. | 2016-09-23 |
| 04015630990634 | AlbuminBCP AlbuminBCP | Roche Diagnostics GmbH | 2016-09-20 |
| 04015630928064 | Albumin BCP | Roche Diagnostics GmbH | 2016-09-20 |
| 00851445007006 | GENCHEM™ Albumin Reagent | GENCHEM INC | 2016-09-19 |
| 05055273200034 | ALB | RANDOX LABORATORIES LIMITED | 2016-09-16 |
| 00817302020229 | CAROLINA LIQUID CHEMISTRIES CORP.™ ALB ALBUMIN REAGENT CC214 | CAROLINA LIQUID CHEMISTRIES CORPORATION | 2016-09-01 |
| 00817302020946 | CAROLINA LIQUID CHEMISTRIES CORP.® ALB RGT.KIT AU-214 | CAROLINA LIQUID CHEMISTRIES CORPORATION | 2016-09-01 |
| 15099590233341 | Synchron | Beckman Coulter, Inc. | 2016-08-24 |
| 15099590625719 | Synchron | Beckman Coulter, Inc. | 2016-08-24 |
| 00380740012816 | ARCHITECT | ABBOTT LABORATORIES | 2016-06-06 |