ETHYL ALCOHOL CLINICAL STANDARD SOLUTIONS
FDA 510(k) clearance K973054 · decided 1997-10-01
Clearance details
- K-number
- K973054
- Device name
- ETHYL ALCOHOL CLINICAL STANDARD SOLUTIONS
- Applicant
- Emd Chemicals, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1997-08-15
- Decision date
- 1997-10-01
- Days to decision
- 47 days
- Clearance type
- Traditional
- Product code
- DNN
- Device class
- 2
- Regulation number
- 862.3200
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Gibbstown, NJ, 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 |
|---|---|---|
| ETHYL ALCOHOL CLINICAL STANDARD SOLUTIONS (K990516) | Emd Chemicals, Inc. | 1999-03-31 |
| ETHYL ALCOHOL CALIBRATORS & CONTROL (K924733) | Diagnostic Reagents, Inc. | 1992-12-09 |
| ETHYL ALCOHOL STANDARD (K882117) | Verichem Laboratories, Inc. | 1988-08-04 |
| ALCOHOL CALIBRATORS (K853532) | Diagnostic Systems | 1985-09-16 |
| ETHYL ALCOHOL SERUM CALIBRATOR (K810466) | Syva Co. | 1981-03-06 |
| EMIT-STM ETHYL ALCOHOL URINE CALIBRATOR (K802620) | Syva Co. | 1980-10-31 |
Recalls involving this device
No recalls on record reference this clearance.