INTERSCI TEST FOR ALCOHOL IN BODY FLUIDS
FDA 510(k) clearance K792469 · decided 1980-01-23
Clearance details
- K-number
- K792469
- Device name
- INTERSCI TEST FOR ALCOHOL IN BODY FLUIDS
- Applicant
- Intersci Corp.
- Decision
- Substantially Equivalent
- Date received
- 1979-12-03
- Decision date
- 1980-01-23
- Days to decision
- 51 days
- Clearance type
- Traditional
- Product code
- DOJ
- Device class
- 2
- Regulation number
- 862.3040
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Mchenry, IL, 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 |
|---|---|---|
| ON-SITE ALCOHOL (K903223) | Toxi-Lab, Inc. | 1991-03-13 |
Recalls involving this device
No recalls on record reference this clearance.