510(k) K903223
K903223 is an FDA 510(k) premarket notification submitted by Toxi-Lab, Inc. for the device "ON-SITE ALCOHOL". The FDA issued a decision of Substantially Equivalent on March 13, 1991. The device falls under product code DOJ (Potassium Dichromate, Alcohol), a Class II device regulated under 21 CFR 862.3040. Toxi-Lab, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 13, 1991
- Date Received
- July 23, 1990
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Potassium Dichromate, Alcohol
- Device Class
- Class II
- Regulation Number
- 862.3040
- Review Panel
- TX
- Submission Type