AGGLUTEX BARBITURATES TEST KIT
FDA 510(k) clearance K812988 · decided 1981-12-31
Clearance details
- K-number
- K812988
- Device name
- AGGLUTEX BARBITURATES TEST KIT
- Applicant
- Hoffmann-La Roche, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1981-10-26
- Decision date
- 1981-12-31
- Days to decision
- 66 days
- Clearance type
- Traditional
- Product code
- DKN
- Device class
- 2
- Regulation number
- 862.3150
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Mchenry, IL, 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 |
|---|---|---|
| ABUSCREEN(R) ONLINE(TM) FOR BARBITURATES (K914468) | Roche Diagnostic Systems, Inc. | 1991-10-30 |
| ABUSCREEN(R) ONTRAK(TM) FOR BARBITURATES (K881816) | Roche Diagnostic Systems, Inc. | 1988-07-28 |
| ABUSCREEN RADIOIMMUNOASSAY-BARBITURATE (K830479) | Hoffmann-La Roche, Inc. | 1983-03-10 |
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 |