CJW
18 FDA 510(k) clearances · Product code
52 daysmedian time to decision
144 days90th percentile
18clearances measured
FDA profile
- Official device name
- Bromcresol Purple Dye-Binding, Albumin
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1035
- Medical specialty
- Clinical Chemistry
- Flags
- Third-party review eligible
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Albumin BCP2 (K203530) | Abbott Ireland Diagnostics Division | 2022-03-18 |
| Albumin BCP (K193001) | SENTINEL CH. SpA | 2019-12-19 |
| ADVIA CHEMISTRY ALBUMIN BCP REAGENT (ALBP), ADVIA CHEMISTRY ALBUMIN BCP CALIBRATOR (K132664) | Siemens Healthcare Diagnostics, Inc. | 2013-10-16 |
| ALBUMIN REAGENT (K021636) | Intersect Systems, Inc. | 2002-07-17 |
| RANDOX ALBUMIN (K000483) | Randox Laboratories, Ltd. | 2000-03-31 |
| ALBUMIN BCG, MODEL AL 103-01 (K990978) | A.P. Total Care, Inc. | 1999-05-25 |
| ALBP (K981814) | Abbott Laboratories | 1998-07-22 |
| ALBP (K981457) | Abbott Mfg., Inc. | 1998-05-27 |
| ABBOTT QUICKSTART ALBUMIN BCP (ALBP)#5A16 (K913025) | Em Diagnostic Systems, Inc. | 1991-10-09 |
| ALBUMIN REAGENT SET (K905776) | Biochemical Trade, Inc. | 1991-02-26 |
| ALBUMIN (BCP) (K863226) | Sigma Diagnostics, Inc. | 1986-09-17 |
| EMDS(TM) ALBUMIN TESTPACKS, #67652/95 (K863004) | Em Diagnostic Systems, Inc. | 1986-09-16 |
| VISION ALBUMIN (K862138) | Abbott Laboratories | 1986-06-17 |
| A-GENT LIQUID ALBUMIN (K860423) | Abbott Laboratories | 1986-03-17 |
| ALBUMIN BCP (K844426) | Boehringer Mannheim Corp. | 1985-01-07 |
| WAKO AUTOMATED REAGENTS FOR HITACHI 705 (K842847) | Wako Chemicals USA, Inc. | 1984-12-11 |
| ALBUMIN PROCEDURE BCP (K832632) | Sandare Chemical Co., Inc. | 1983-09-12 |
| QUANTIMETRIX BROMERESOL PURPLE ALBUMIN (K830934) | Quantimetrix Corp. | 1983-04-18 |
Track CJW automatically
Every clearance here is in the API, with alerts when new ones post.