REFERENCE MATERIAL FOR AMPHETAMINE/METHAMPHETAMINE IN HUMAN URINE
FDA 510(k) clearance K974699 · decided 1998-01-22
Clearance details
- K-number
- K974699
- Device name
- REFERENCE MATERIAL FOR AMPHETAMINE/METHAMPHETAMINE IN HUMAN URINE
- Applicant
- Consolidated Technologies, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1997-12-16
- Decision date
- 1998-01-22
- Days to decision
- 37 days
- Clearance type
- Traditional
- Product code
- DKB
- Device class
- 2
- Regulation number
- 862.3200
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Austin, TX, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.