BRANAN MEDICAL CORPERATION MONITECT TCA DRUG SCREEN TEST, MODEL MC21 AND MD21
FDA 510(k) clearance K010734 · decided 2001-07-30
Clearance details
- K-number
- K010734
- Device name
- BRANAN MEDICAL CORPERATION MONITECT TCA DRUG SCREEN TEST, MODEL MC21 AND MD21
- Applicant
- Branan Medical Corp.
- Decision
- Substantially Equivalent
- Date received
- 2001-03-12
- Decision date
- 2001-07-30
- Days to decision
- 140 days
- Clearance type
- Traditional
- Product code
- MLK
- Device class
- 2
- Regulation number
- 862.3910
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Irvine, 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 |
|---|---|---|
| INSTANT-VIEW TCA URINE TEST (K022693) | Alfa Scientific Designs, Inc. | 2002-12-09 |
Recalls involving this device
No recalls on record reference this clearance.