ABUSCREEN RADIOIMMUNOASSAY - AMPHETAMINE
FDA 510(k) clearance K823212 · decided 1982-11-29
Clearance details
- K-number
- K823212
- Device name
- ABUSCREEN RADIOIMMUNOASSAY - AMPHETAMINE
- Applicant
- Hoffmann-La Roche, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1982-10-28
- Decision date
- 1982-11-29
- Days to decision
- 32 days
- Clearance type
- Traditional
- Product code
- DJP
- Device class
- 2
- Regulation number
- 862.3100
- 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 |
|---|---|---|
| PRIMIDONE EIA TEST (K960526) | Diagnostic Reagents, Inc. | 1996-03-18 |
| URINE AMPHETAMINE DIRECT RIA KIT (I-125) (K913866) | Immunalysis Corporation | 1991-09-25 |
| ABUSCREEN RADIOIMMUNOASSAY FOR AMPHETAMINE (K912755) | Roche Diagnostic Systems, Inc. | 1991-08-26 |
| REVISED DOUBLE ANTIBODY AMPHETAMINE (K882228) | Diagnostic Products Corp. | 1988-08-08 |
| ABUSCREEN(R) ONTRAK(TM) FOR AMPHETAMINES (K881817) | Roche Diagnostic Systems, Inc. | 1988-07-29 |
| ABUSCREEN RADIOIMMUNOASSAY FOR AMPHETAMINE-HIGH SP (K854009) | Roche Diagnostic Systems, Inc. | 1985-10-15 |
| ABUSCREEN RADIOIMMUNOASSAY-AMPHETAMINE (K830482) | Hoffmann-La Roche, Inc. | 1983-03-24 |
| AGGLUTEX AMPHETAMINE TEST KIT (K812986) | Hoffmann-La Roche, Inc. | 1982-01-22 |
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 |