INSTANT-VIEW TCA URINE TEST
FDA 510(k) clearance K022693 · decided 2002-12-09
Clearance details
- K-number
- K022693
- Device name
- INSTANT-VIEW TCA URINE TEST
- Applicant
- Alfa Scientific Designs, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2002-08-13
- Decision date
- 2002-12-09
- Days to decision
- 118 days
- Clearance type
- Abbreviated
- Product code
- MLK
- Device class
- 2
- Regulation number
- 862.3910
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Poway, CA, 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 |
|---|---|---|
| BRANAN MEDICAL CORPERATION MONITECT TCA DRUG SCREEN TEST, MODEL MC21 AND MD21 (K010734) | Branan Medical Corp. | 2001-07-30 |
Recalls involving this device
No recalls on record reference this clearance.