ETHYL ALCOHOL CALIBRATORS & CONTROL
FDA 510(k) clearance K924733 · decided 1992-12-09
Clearance details
- K-number
- K924733
- Device name
- ETHYL ALCOHOL CALIBRATORS & CONTROL
- Applicant
- Diagnostic Reagents, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1992-09-22
- Decision date
- 1992-12-09
- Days to decision
- 78 days
- Clearance type
- Traditional
- Product code
- DNN
- Device class
- 2
- Regulation number
- 862.3200
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Mountain View, 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 |
|---|---|---|
| ETHYL ALCOHOL CLINICAL STANDARD SOLUTIONS (K990516) | Emd Chemicals, Inc. | 1999-03-31 |
| ETHYL ALCOHOL CLINICAL STANDARD SOLUTIONS (K973054) | Emd Chemicals, Inc. | 1997-10-01 |
| 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.