TEST, IN-VITRO DIAGNOSTIC
FDA 510(k) clearance K760089 · decided 1976-07-20
Clearance details
- K-number
- K760089
- Device name
- TEST, IN-VITRO DIAGNOSTIC
- Applicant
- Hoffmann-La Roche, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1976-06-21
- Decision date
- 1976-07-20
- Days to decision
- 29 days
- Clearance type
- Traditional
- Advisory committee
- Unknown
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| CEA-ROCHE TEST KIT (P800063/S004) | Hoffmann-La Roche, Inc. | 1983-10-18 |
| CEA-ROCHE TEST KIT (P800063/S003) | Hoffmann-La Roche, Inc. | 1982-10-21 |
| CEA-ROCHE TEST KIT (P800063/S002) | Hoffmann-La Roche, Inc. | 1982-09-16 |
| CEA-ROCHE TEST KIT (P800063/S001) | Hoffmann-La Roche, Inc. | 1982-03-03 |