FDA Product Code
FDA Product Code NCW — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Immunology
- 21 CFR Citation
- 866.6010
510(k) Clearances — 3 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K024017 | BAYER ADVIA CENTAUR HER-2/NEU ASSAY | Bayer Corp. | 2003-01-30 | Traditional | PDF ↗ |
| K992228 | BAYER IMMUNO 1 HER-2/NEU ASSAY | Bayer Corp. | 2000-09-29 | Traditional | PDF ↗ |
| K994112 | MANUAL HER-2/NEU MICROTITER ELISA (OSDI HER-2/NEU ELISA) | Oncogene Science, Inc. | 2000-09-29 | Traditional | PDF ↗ |
Product code NCW · Class II · Immunology. Data: openFDA.