Emit D.A.U. Amphetamine Assay
FDA 510(k) K842674 · Syva Co.
510(k) numberK842674
Submission
- Device name
- Emit D.A.U. Amphetamine Assay
- Applicant
- Syva Co.
Mchenry, IL, US - Received
- July 10, 1984
- Decision date
- September 26, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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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| K993980 | Syva Emit II Plus Ethyl Alcohol Assay, Models 9K309UL/9K409ULDML · Traditional | 02/01/2000SE |
| K993988 | Syva Emit II Plus Cocaine Metabolite Assay, Model 9H029ULDIO · Traditional | 01/27/2000SE |
| K993987 | Syva Emit II Plus Barbiturate Assay, Model 9D029UL/9D129ULKLT · Traditional | 01/27/2000SE |
| K993986 | Syva Emit II Plus Methaqualone Assay, Model 9Q029UL/9Q129ULKXS · Traditional | 01/27/2000SE |
Questions and answers
When was Emit D.A.U. Amphetamine Assay cleared by the FDA?
Emit D.A.U. Amphetamine Assay (K842674) received a 510(k) decision of Substantially Equivalent on September 26, 1984, 78 days after the submission was received.
What is the product code of K842674?
The FDA product code is DKZ – Enzyme Immunoassay, Amphetamine, a Class II (moderate risk) device regulated under 21 CFR 862.3100.