FDA Product Code
FDA Product Code CJW — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1035
510(k) Clearances — 18 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K203530 | Albumin BCP2 | Abbott Ireland Diagnostics Division | 2022-03-18 | Traditional | PDF ↗ |
| K193001 | Albumin BCP | SENTINEL CH. SpA | 2019-12-19 | Traditional | PDF ↗ |
| K132664 | ADVIA CHEMISTRY ALBUMIN BCP REAGENT (ALBP), ADVIA CHEMISTRY ALBUMIN BCP CALIBRATOR | Siemens Healthcare Diagnostics, Inc. | 2013-10-16 | Traditional | PDF ↗ |
| K021636 | ALBUMIN REAGENT | Intersect Systems, Inc. | 2002-07-17 | Traditional | PDF ↗ |
| K000483 | RANDOX ALBUMIN | Randox Laboratories, Ltd. | 2000-03-31 | Traditional | PDF ↗ |
| K990978 | ALBUMIN BCG, MODEL AL 103-01 | A.P. Total Care, Inc. | 1999-05-25 | Traditional | PDF ↗ |
| K981814 | ALBP | Abbott Laboratories | 1998-07-22 | Traditional | PDF ↗ |
| K981457 | ALBP | Abbott Mfg., Inc. | 1998-05-27 | Traditional | PDF ↗ |
| K913025 | ABBOTT QUICKSTART ALBUMIN BCP (ALBP)#5A16 | Em Diagnostic Systems, Inc. | 1991-10-09 | Traditional | PDF ↗ |
| K905776 | ALBUMIN REAGENT SET | Biochemical Trade, Inc. | 1991-02-26 | Traditional | PDF ↗ |
| K863226 | ALBUMIN (BCP) | Sigma Diagnostics, Inc. | 1986-09-17 | Traditional | PDF ↗ |
| K863004 | EMDS(TM) ALBUMIN TESTPACKS, #67652/95 | Em Diagnostic Systems, Inc. | 1986-09-16 | Traditional | PDF ↗ |
| K862138 | VISION ALBUMIN | Abbott Laboratories | 1986-06-17 | Traditional | PDF ↗ |
| K860423 | A-GENT LIQUID ALBUMIN | Abbott Laboratories | 1986-03-17 | Traditional | PDF ↗ |
| K844426 | ALBUMIN BCP | Boehringer Mannheim Corp. | 1985-01-07 | Traditional | PDF ↗ |
| K842847 | WAKO AUTOMATED REAGENTS FOR HITACHI 705 | Wako Chemicals USA, Inc. | 1984-12-11 | Traditional | PDF ↗ |
| K832632 | ALBUMIN PROCEDURE BCP | Sandare Chemical Co., Inc. | 1983-09-12 | Traditional | PDF ↗ |
| K830934 | QUANTIMETRIX BROMERESOL PURPLE ALBUMIN | Quantimetrix Corp. | 1983-04-18 | Traditional | PDF ↗ |
Product code CJW · Class II · Clinical Chemistry. Data: openFDA.