Easy-Test Alcohol (Alc), Item No. 67515/93
FDA 510(k) K864894 · Em Diagnostic Systems, Inc.
510(k) numberK864894
Submission
- Device name
- Easy-Test Alcohol (Alc), Item No. 67515/93
- Applicant
- Em Diagnostic Systems, Inc.
Gibbstown, NJ, US - Received
- December 15, 1986
- Decision date
- January 9, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DMT – Enzymatic Method, Alcohol Dehydrogenase, Ultraviolet
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3040
- Specialty
- Clinical Toxicology
Other 510(k)s with product code DMT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K000410 | Synchron Systems Alcohol Reagent and CalibratorsDMT · Traditional | Beckman Coulter, Inc. | 04/10/2000SE |
| K971506 | Synchron Systems Alcohol (Alc) Reagent, Synchron Systems Alcohol CalibratorDMT · Traditional | Beckman Instruments, Inc. | 06/03/1997SE |
| K934273 | Kodak Ektachem Clinical Chemistry Slide Alcohol (Alc)DMT · Traditional | Eastman Kodak Company | 03/21/1994SE |
| K923783 | Ethyl Alcohol AssayDMT · Traditional | Diagnostic Reagents, Inc. | 01/21/1993SE |
| K843378 | Ethyl Alcohol Assay KitDMT · Traditional | Diagnostic Chemicals, Ltd. (Usa) | 09/14/1984SE |
| K810467 | Emit-St Serum Ethyl Alcohol AssayDMT · Traditional | Syva Co. | 03/06/1981SE |
| K802621 | Emit-Stm Ethyl Alcohol AssayDMT · Traditional | Syva Co. | 10/31/1980SE |
More from Syva Co.
| 510(k) | Device | Decision |
|---|---|---|
| K935181 | Aspartate Aminotransferase (Ast) TestCIT · Traditional | 01/27/1994SE |
| K935180 | Alanine Aminotransferase (Alt) TestCKA · Traditional | 01/13/1994SE |
| K935179 | Emds Albumin (Alb) TestCIX · Traditional | 12/17/1993SE |
| K935178 | Emds Phosphorous (Phos) TestCEO · Traditional | 12/17/1993SE |
| K935177 | Gamma-Glutamyl Transferase (GGT) TestJQB · Traditional | 12/16/1993SE |
| K935176 | Iron TestJIY · Traditional | 12/16/1993SE |
| K935175 | Lactate Dehydrogenase (LD)CFJ · Traditional | 12/16/1993SE |
| K935174 | Total Protein Test (Tpro)CEK · Traditional | 12/16/1993SE |
| K935136 | Cholesterol (Chol) Test Item No. 65410CHH · Traditional | 12/16/1993SE |
| K935183 | Emds Magnesium (MG) TestJGJ · Traditional | 12/09/1993SE |
Questions and answers
When was Easy-Test Alcohol (Alc), Item No. 67515/93 cleared by the FDA?
Easy-Test Alcohol (Alc), Item No. 67515/93 (K864894) received a 510(k) decision of Substantially Equivalent on January 9, 1987, 25 days after the submission was received.
What is the product code of K864894?
The FDA product code is DMT – Enzymatic Method, Alcohol Dehydrogenase, Ultraviolet, a Class II (moderate risk) device regulated under 21 CFR 862.3040.