Amphetamine Test System
FDA 510(k) K934693 · U.S. Drug Testing, Inc.
510(k) numberK934693
Submission
- Device name
- Amphetamine Test System
- Applicant
- U.S. Drug Testing, Inc.
Rancho Cucamonga, CA, US - Received
- September 30, 1993
- Decision date
- November 22, 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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| K940912 | Usdt Cannabinoid (THC) Assay Column Catalog No. 9000-500LDJ · Traditional | 06/02/1994SE |
| K935629 | Usdt Phencyclidine (PCP) Assay Column Cat. No. 9000-400LCM · Traditional | 04/12/1994SE |
| K932318 | Usdt Opiate Assay Column Catalog No. 9000-200DJG · Traditional | 06/15/1993SE |
| K931227 | Usdt Flow Immunoassay System, Model 9000KZR · Traditional | 05/06/1993SE |
| K930985 | Usdt Cocaine/Cocaine Metabol Assay COLUMN,9000-100DIO · Traditional | 04/27/1993SE |
Questions and answers
When was Amphetamine Test System cleared by the FDA?
Amphetamine Test System (K934693) received a 510(k) decision of Substantially Equivalent on November 22, 1993, 53 days after the submission was received.
What is the product code of K934693?
The FDA product code is DKZ – Enzyme Immunoassay, Amphetamine, a Class II (moderate risk) device regulated under 21 CFR 862.3100.