ABUSCREEN RADIOUMMUNOASSAY--URINE
FDA 510(k) clearance K830462 · decided 1983-03-24
Clearance details
- K-number
- K830462
- Device name
- ABUSCREEN RADIOUMMUNOASSAY--URINE
- Applicant
- Hoffmann-La Roche, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1983-02-15
- Decision date
- 1983-03-24
- Days to decision
- 37 days
- Clearance type
- Traditional
- Product code
- DOE
- Device class
- 2
- Regulation number
- 862.3640
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Hoffmann-La Roche
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
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 |