ABUSCREEN RADIOIMMUNOASSAY FOR METHAMPHETAMINE
FDA 510(k) clearance K912754 · decided 1991-09-27
Clearance details
- K-number
- K912754
- Device name
- ABUSCREEN RADIOIMMUNOASSAY FOR METHAMPHETAMINE
- Applicant
- Roche Diagnostic Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1991-06-21
- Decision date
- 1991-09-27
- Days to decision
- 98 days
- Clearance type
- Traditional
- Product code
- DPJ
- Device class
- 2
- Regulation number
- 862.3100
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Montclair, NJ, 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) RADIOIMMUNOASSAY FOR METHAMPHE/AMPHET (K913911) | Roche Diagnostic Systems, Inc. | 1991-11-01 |
Recalls involving this device
No recalls on record reference this clearance.