SYNCHRON SYSTEMS ALCOHOL (ALC) REAGENT, SYNCHRON SYSTEMS ALCOHOL CALIBRATOR
FDA 510(k) clearance K971506 · decided 1997-06-03
Clearance details
- K-number
- K971506
- Device name
- SYNCHRON SYSTEMS ALCOHOL (ALC) REAGENT, SYNCHRON SYSTEMS ALCOHOL CALIBRATOR
- Applicant
- Beckman Instruments, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1997-04-25
- Decision date
- 1997-06-03
- Days to decision
- 39 days
- Clearance type
- Traditional
- Product code
- DMT
- Device class
- 2
- Regulation number
- 862.3040
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Brea, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| SYNCHRON SYSTEMS ALCOHOL REAGENT AND CALIBRATORS (K000410) | Beckman Coulter, Inc. | 2000-04-10 |
| KODAK EKTACHEM CLINICAL CHEMISTRY SLIDE ALCOHOL (ALC) (K934273) | Eastman Kodak Company | 1994-03-21 |
| ETHYL ALCOHOL ASSAY (K923783) | Diagnostic Reagents, Inc. | 1993-01-21 |
| EASY-TEST ALCOHOL (ALC), ITEM NO. 67515/93 (K864894) | Em Diagnostic Systems, Inc. | 1987-01-09 |
| ETHYL ALCOHOL ASSAY KIT (K843378) | Diagnostic Chemicals, Ltd. (Usa) | 1984-09-14 |
| EMIT-ST SERUM ETHYL ALCOHOL ASSAY (K810467) | Syva Co. | 1981-03-06 |
| EMIT-STM ETHYL ALCOHOL ASSAY (K802621) | Syva Co. | 1980-10-31 |
Recalls involving this device
No recalls on record reference this clearance.