CJW — Bromcresol Purple Dye-Binding, Albumin Class II
FDA product code CJW covers "Bromcresol Purple Dye-Binding, Albumin", a Class II medical device regulated under 21 CFR 862.1035. Submissions are reviewed by the Clinical Chemistry panel. At least 18 recent 510(k) clearances have been granted under this product code.
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 |