Emit ST Urine Ethyl Alcohol Assay
FDA 510(k) K840171 · Syva Co.
510(k) numberK840171
Submission
- Device name
- Emit ST Urine Ethyl Alcohol Assay
- Applicant
- Syva Co.
Mchenry, IL, US - Received
- January 17, 1984
- Decision date
- March 19, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DML – Nad-Nadh, Specific Reagent For Alcohol Enzyme Method
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3040
- Specialty
- Clinical Toxicology
Other 510(k)s with product code DML
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K013538 | EthanolDML · Traditional | Abbott Laboratories | 12/14/2001SE |
| K993980 | Syva Emit II Plus Ethyl Alcohol Assay, Models 9K309UL/9K409ULDML · Traditional | Syva Co. | 02/01/2000SE |
| K963197 | On.Site AlcoholDML · Traditional | Ansys, Inc. | 09/19/1996SE |
| K953765 | Axsym Rea EthanolDML · Traditional | Abbott Laboratories | 09/27/1995SE |
| K952839 | Boehringer Mannheim Ethyl Alcohol AssayDML · Traditional | Boehringer Mannheim Corp. | 08/24/1995SE |
| K923337 | On*Site AlcoholDML · Traditional | Toxi-Lab, Inc. | 01/12/1993SE |
| K914777 | Sigma Procedure No. 333-UVDML · Traditional | Sigma Diagnostics, Inc. | 12/27/1991SE |
| K874382 | Raichem(Tm) Alcohol ReagentDML · Traditional | Reagents Applications, Inc. | 01/11/1988SE |
| K872180 | Kinetic 610 EthanolDML · Traditional | American Monitor Corp. | 07/07/1987SE |
| K863419 | Emds(Tm) Alcohol Testpacks, #67691/95DML · Traditional | Em Diagnostic Systems, Inc. | 09/29/1986SE |
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| K011878 | Emit (R) Tox Salicylic Assay, Model 7SO19UL, Emit (R) Tox Salicylic Acid Calibrators…DKJ · Traditional | 08/13/2001SE |
| K012257 | Emit II Plus Monoclonal Amphetamine/Methamphetamine Assay Model OSR9C229DKZ · Special | 08/03/2001SE |
| K011947 | Emit 2000 Valproic Acid Assay, Model OSR4G229ULLEG · Special | 07/02/2001SE |
| K011528 | Emit 2000 Phenobarbital Assay, Model OSR4D229DLZ · Special | 06/06/2001SE |
| K011347 | Emit 2000 Phenytoin Assay, Model 0SR4A229DIP · Special | 05/17/2001SE |
| K993981 | Syva Emit II Plus Propoxyphene Assay, Models 9G029UL/9G129ULJXN · Traditional | 02/01/2000SE |
| 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 ST Urine Ethyl Alcohol Assay cleared by the FDA?
Emit ST Urine Ethyl Alcohol Assay (K840171) received a 510(k) decision of Substantially Equivalent on March 19, 1984, 62 days after the submission was received.
What is the product code of K840171?
The FDA product code is DML – Nad-Nadh, Specific Reagent For Alcohol Enzyme Method, a Class II (moderate risk) device regulated under 21 CFR 862.3040.