CJW — Bromcresol Purple Dye-Binding, Albumin Class II
FDA Device Classification
Classification Details
- Product Code
- CJW
- Device Class
- Class II
- Regulation Number
- 862.1035
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K203530 | abbott ireland diagnostics division | Albumin BCP2 | March 18, 2022 |
| K193001 | sentinel ch | Albumin BCP | December 19, 2019 |
| K132664 | siemens healthcare diagnostics | ADVIA CHEMISTRY ALBUMIN BCP REAGENT (ALBP), ADVIA CHEMISTRY ALBUMIN BCP CALIBRAT | October 16, 2013 |
| K021636 | intersect systems | ALBUMIN REAGENT | July 17, 2002 |
| K000483 | randox laboratories | RANDOX ALBUMIN | March 31, 2000 |
| K990978 | a.p. total care | ALBUMIN BCG, MODEL AL 103-01 | May 25, 1999 |
| K981814 | abbott laboratories | ALBP | July 22, 1998 |
| K981457 | abbott mfg | ALBP | May 27, 1998 |
| K913025 | em diagnostic systems | ABBOTT QUICKSTART ALBUMIN BCP (ALBP)#5A16 | October 9, 1991 |
| K905776 | biochemical trade | ALBUMIN REAGENT SET | February 26, 1991 |
| K863226 | sigma diagnostics | ALBUMIN (BCP) | September 17, 1986 |
| K863004 | em diagnostic systems | EMDS(TM) ALBUMIN TESTPACKS, #67652/95 | September 16, 1986 |
| K862138 | abbott laboratories | VISION ALBUMIN | June 17, 1986 |
| K860423 | abbott laboratories | A-GENT LIQUID ALBUMIN | March 17, 1986 |
| K844426 | boehringer mannheim | ALBUMIN BCP | January 7, 1985 |
| K842847 | wako chemicals usa | WAKO AUTOMATED REAGENTS FOR HITACHI 705 | December 11, 1984 |
| K832632 | sandare chemical co | ALBUMIN PROCEDURE BCP | September 12, 1983 |
| K830934 | quantimetrix | QUANTIMETRIX BROMERESOL PURPLE ALBUMIN | April 18, 1983 |