Micro Eia for Amphetamine Metabolites
FDA 510(k) K932304 · Microdiagnostics, Inc.
510(k) numberK932304
Submission
- Device name
- Micro Eia for Amphetamine Metabolites
- Applicant
- Microdiagnostics, Inc.
Laguna Niguel, CA, US - Received
- May 12, 1993
- Decision date
- December 7, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
|---|---|---|
| K011952 | Drugs of Abuse Multi-Test StripDKZ · Traditional | 10/25/2001SE |
| K991516 | Micro-Strip for Marijuana MetabolitesLDJ · Traditional | 08/05/1999SE |
| K991505 | Micro-Strip for Phencyclidine MetabolitesLCM · Traditional | 08/05/1999SE |
| K981388 | Micro-Strip for Cocaine MetabolitesDIO · Traditional | 05/29/1998SE |
| K974611 | Micro-Strip for Amphetamine MetabolitesDKZ · Traditional | 03/20/1998SE |
| K973761 | Micro-Strip for Opiate MetabolitesDJG · Traditional | 12/24/1997SE |
| K923468 | Micro Eia for Opiate MetabolitesDJG · Traditional | 09/15/1992SE |
| K914533 | Micro Eia for Cocaine MetabolitesDIO · Traditional | 12/10/1991SE |
| K914490 | Micro Eia for Marijuana MetabolitesLDJ · Traditional | 11/29/1991SE |
Questions and answers
When was Micro Eia for Amphetamine Metabolites cleared by the FDA?
Micro Eia for Amphetamine Metabolites (K932304) received a 510(k) decision of Substantially Equivalent on December 7, 1993, 209 days after the submission was received.
What is the product code of K932304?
The FDA product code is DKZ – Enzyme Immunoassay, Amphetamine, a Class II (moderate risk) device regulated under 21 CFR 862.3100.