510(k) K792469
- Device
- Intersci Test For Alcohol In Body Fluids
- Applicant
- INTERSCI CORP.
- 510(k) number
- K792469
- Product code
- DOJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1980-01-23
- Date received
- 1979-12-03
- Regulation
- 862.3040
- Classification name
- Potassium Dichromate, Alcohol
- Medical specialty
- Clinical Toxicology
- Review panel
- Clinical Toxicology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code DOJ#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K903223 | ON-SITE ALCOHOL | Toxi-Lab, Inc. | 1991-03-13 |