510(k) K022693
- Device
- INSTANT-VIEW TCA URINE TEST
- Applicant
- ALFA SCIENTIFIC DESIGNS, INC.
- 510(k) number
- K022693
- Product code
- MLK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2002-12-09
- Date received
- 2002-08-13
- Regulation
- 862.3910
- Classification name
- Thin Layer Chromatography, Tricyclic Antidepressant Drugs
- Medical specialty
- Toxicology
- Review panel
- Toxicology
- Device class
- 2
- Clearance type
- Abbreviated
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- NAISHU WANG
- Address
- 12330 Stowe Dr. Poway CA US 92064 92064
FDA Registration Numbers#
- 2060833
- 2020952
- 2029372
Source Documents#
Other 510(k) Records For Product Code MLK #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K010734 | BRANAN MEDICAL CORPERATION MONITECT TCA DRUG SCREEN TEST, MODEL MC21 AND MD21 | Branan Medical Corp. | 2001-07-30 |
Legacy Summary#
summary
FDA Review#
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