Emit-St Serum Ethyl Alcohol Assay
FDA 510(k) K810467 · Syva Co.
510(k) numberK810467
Submission
- Device name
- Emit-St Serum Ethyl Alcohol Assay
- Applicant
- Syva Co.
Mchenry, IL, US - Received
- February 23, 1981
- Decision date
- March 6, 1981
- 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 |
| K864894 | Easy-Test Alcohol (Alc), Item No. 67515/93DMT · Traditional | Em Diagnostic Systems, Inc. | 01/09/1987SE |
| K843378 | Ethyl Alcohol Assay KitDMT · Traditional | Diagnostic Chemicals, Ltd. (Usa) | 09/14/1984SE |
| K802621 | Emit-Stm Ethyl Alcohol AssayDMT · Traditional | Syva Co. | 10/31/1980SE |
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Questions and answers
When was Emit-St Serum Ethyl Alcohol Assay cleared by the FDA?
Emit-St Serum Ethyl Alcohol Assay (K810467) received a 510(k) decision of Substantially Equivalent on March 6, 1981, 11 days after the submission was received.
What is the product code of K810467?
The FDA product code is DMT – Enzymatic Method, Alcohol Dehydrogenase, Ultraviolet, a Class II (moderate risk) device regulated under 21 CFR 862.3040.