510(k) K903223
- Device
- ON-SITE ALCOHOL
- Applicant
- TOXI-LAB, INC.
- 510(k) number
- K903223
- Product code
- DOJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1991-03-13
- Date received
- 1990-07-23
- Regulation
- 862.3040
- Classification name
- Potassium Dichromate, Alcohol
- Medical specialty
- Toxicology
- Review panel
- Toxicology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- MICHAEL O'DONNELL
- Address
- 2 Goodyear Irvine CA US 92718 92718
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code DOJ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K792469 | INTERSCI TEST FOR ALCOHOL IN BODY FLUIDS | Intersci Corp. | 1980-01-23 |
Legacy Summary#
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FDA Review#
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