510(k) K971506
- Device
- SYNCHRON SYSTEMS ALCOHOL (ALC) REAGENT, SYNCHRON SYSTEMS ALCOHOL CALIBRATOR
- Applicant
- BECKMAN INSTRUMENTS, INC.
- 510(k) number
- K971506
- Product code
- DMT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1997-06-03
- Date received
- 1997-04-25
- 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
- SHERI HALL
- Address
- 200 S. Kraemer Blvd. W-337 Brea CA US 92821 92821
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 |
|---|---|---|---|
| K000410 | SYNCHRON SYSTEMS ALCOHOL REAGENT AND CALIBRATORS | Beckman Coulter, Inc. | 2000-04-10 |
| 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#
summary
FDA Review#
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