Microline Screen for Amphetamine
FDA 510(k) K935052 · Drug Screening Systems, Inc.
510(k) numberK935052
Submission
- Device name
- Microline Screen for Amphetamine
- Applicant
- Drug Screening Systems, Inc.
Blackwood, NJ, US - Received
- October 20, 1993
- Decision date
- September 16, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DKZ – Enzyme Immunoassay, Amphetamine
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3100
- Specialty
- Clinical Toxicology
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More from Alfa Scientific Designs, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K945829 | Microline Screen for BenzodiazepineJXM · Traditional | 01/25/1995SE |
| K933480 | Microline Screen for BarbituratesDIS · Traditional | 10/29/1993SE |
| K921651 | Microline Screen for PhencyclidineLCM · Traditional | 07/08/1992SE |
| K914915 | Microline Screen for CannabinoidLDJ · Traditional | 01/22/1992SE |
| K911652 | Mircoline Screen for CocaineDIO · Traditional | 05/15/1991SE |
| K910525 | Microline Screen for MethamphetamineDIT · Traditional | 04/05/1991SE |
| K905491 | Microline Screen for OpiatesDJG · Traditional | 03/13/1991SE |
Questions and answers
When was Microline Screen for Amphetamine cleared by the FDA?
Microline Screen for Amphetamine (K935052) received a 510(k) decision of Substantially Equivalent on September 16, 1994, 331 days after the submission was received.
What is the product code of K935052?
The FDA product code is DKZ – Enzyme Immunoassay, Amphetamine, a Class II (moderate risk) device regulated under 21 CFR 862.3100.