510(k) K994409
- Device
- INSTANT-VIEW OPIATES/MORPHINE URINE DIP STRIP TEST
- Applicant
- ALFA SCIENTIFIC DESIGNS, INC.
- 510(k) number
- K994409
- Product code
- DPK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2000-07-10
- Date received
- 1999-12-28
- Regulation
- 862.3640
- Classification name
- Liquid Chromatography, Morphine
- Medical specialty
- Toxicology
- Review panel
- Toxicology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- NAISHU WANG
- Address
- 11494 Sorrento Valley Rd., Suite F/M San Diego CA US 92121 92121
FDA Registration Numbers#
- 3003791481
- 2060833
Source Documents#
Other 510(k) Records For Product Code DPK #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K994404 | INSTANT-VIEW MORPHINE URINE CASSETTE TEST | Alfa Scientific Designs, Inc. | 2000-07-05 |
Legacy Summary#
summary
FDA Review#
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