510(k) K792469
K792469 is an FDA 510(k) premarket notification submitted by Intersci Corp. for the device "INTERSCI TEST FOR ALCOHOL IN BODY FLUIDS". The FDA issued a decision of Substantially Equivalent on January 23, 1980. The device falls under product code DOJ (Potassium Dichromate, Alcohol), a Class II device regulated under 21 CFR 862.3040.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 23, 1980
- Date Received
- December 3, 1979
- 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