MANUAL HER-2/NEU MICROTITER ELISA (OSDI HER-2/NEU ELISA)
FDA 510(k) clearance K994112 · decided 2000-09-29
Clearance details
- K-number
- K994112
- Device name
- MANUAL HER-2/NEU MICROTITER ELISA (OSDI HER-2/NEU ELISA)
- Applicant
- Oncogene Science, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1999-12-06
- Decision date
- 2000-09-29
- Days to decision
- 298 days
- Clearance type
- Traditional
- Product code
- NCW
- Device class
- 2
- Regulation number
- 866.6010
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Cambridge, MA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| BAYER ADVIA CENTAUR HER-2/NEU ASSAY (K024017) | Bayer Corp. | 2003-01-30 |
| BAYER IMMUNO 1 HER-2/NEU ASSAY (K992228) | Bayer Corp. | 2000-09-29 |
Recalls involving this device
No recalls on record reference this clearance.