510(k) K000410
- Device
- SYNCHRON SYSTEMS ALCOHOL REAGENT AND CALIBRATORS
- Applicant
- BECKMAN COULTER, INC.
- 510(k) number
- K000410
- Product code
- DMT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2000-04-10
- Date received
- 2000-02-08
- Regulation
- 862.3040
- Classification name
- Enzymatic Method, Alcohol Dehydrogenase, Ultraviolet
- Medical specialty
- Toxicology
- Review panel
- Toxicology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- LUCINDA STOCKERT
- Address
- 200 S. Kraemer Blvd.,M/S W-104 Box 8000 Brea CA US 92822 92822
FDA Registration Numbers#
- 3010939897
- 2250051
- 3012963943
- 2030861
- 1319681
- 3003561301
- 3000308930
- 2050010
- 3005333358
- 2050012
- 1319809
- 1319808
- 3002642396
Source Documents#
Other 510(k) Records For Product Code DMT #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K864894 | EASY-TEST ALCOHOL (ALC), ITEM NO. 67515/93 | Em Diagnostic Systems, Inc. | 1987-01-09 |
| 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 |
Legacy Summary#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases