REVISED LABELING FOR ABUSCREEN EIA BARBITURATE
FDA 510(k) clearance K874210 · decided 1987-11-13
Clearance details
- K-number
- K874210
- Device name
- REVISED LABELING FOR ABUSCREEN EIA BARBITURATE
- Applicant
- Roche Diagnostic Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1987-10-16
- Decision date
- 1987-11-13
- Days to decision
- 28 days
- Clearance type
- Traditional
- Product code
- DIS
- Device class
- 2
- Regulation number
- 862.3150
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Nutley, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.