510(k) K864894
- Device
- Easy-test Alcohol (alc), Item No. 67515/93
- Applicant
- EM DIAGNOSTIC SYSTEMS, INC.
- 510(k) number
- K864894
- Product code
- DMT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1987-01-09
- Date received
- 1986-12-15
- Regulation
- 862.3040
- Classification name
- Enzymatic Method, Alcohol Dehydrogenase, Ultraviolet
- Medical specialty
- Clinical Toxicology
- Review panel
- Clinical Toxicology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- RAYMOND L MILLER
- Address
- 480 Democrat Rd. Gibbstown NJ US 08027 08027
FDA Registration Numbers#
- 3003561301
- 3012963943
- 3010939897
- 2030861
- 3002642396
- 2250051
- 2050010
- 3005333358
- 2050012
- 1319809
- 1319808
- 3000308930
- 1319681
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code DMT#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K000410 | SYNCHRON SYSTEMS ALCOHOL REAGENT AND CALIBRATORS | Beckman Coulter, Inc. | 2000-04-10 |
| K971506 | SYNCHRON SYSTEMS ALCOHOL (ALC) REAGENT, SYNCHRON SYSTEMS ALCOHOL CALIBRATOR | Beckman Instruments, Inc. | 1997-06-03 |
| K934273 | KODAK EKTACHEM CLINICAL CHEMISTRY SLIDE ALCOHOL (ALC) | Eastman Kodak Company | 1994-03-21 |
| K923783 | ETHYL ALCOHOL ASSAY | Diagnostic Reagents, Inc. | 1993-01-21 |
| K843378 | ETHYL ALCOHOL ASSAY KIT | Diagnostic Chemicals, Ltd. (Usa) | 1984-09-14 |
| K810467 | EMIT-ST SERUM ETHYL ALCOHOL ASSAY | Syva Co. | 1981-03-06 |
| K802621 | EMIT-STM ETHYL ALCOHOL ASSAY | Syva Co. | 1980-10-31 |