ETHYL ALCOHOL STANDARD
FDA 510(k) clearance K882117 · decided 1988-08-04
Clearance details
- K-number
- K882117
- Device name
- ETHYL ALCOHOL STANDARD
- Applicant
- Verichem Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1988-05-19
- Decision date
- 1988-08-04
- Days to decision
- 77 days
- Clearance type
- Traditional
- Product code
- DNN
- Device class
- 2
- Regulation number
- 862.3200
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Providence, RI, 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 CALIBRATORS & CONTROL (K924733) | Diagnostic Reagents, Inc. | 1992-12-09 |
| 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
| Record | Firm | Date |
|---|---|---|
| Mega Diagnostics Alcohol Standard (Cat.# A7504-STD) packaged in 5ml vials. recall (Z-0744-2007) | Mega Diagnostics | 2007-04-14 |
| Alcohol Standard, 100 mg/dl, Pointe Scientific Inc., Canton, MI; Catalog # A7504-STD. recall (Z-1545-06) | Pointe Scientific, Inc. | 2006-09-30 |
| Alcohol Standard sold by Pointe Scientific; Catalog # 7-A7504-STD. recall (Z-1549-06) | Pointe Scientific, Inc. | 2006-09-30 |