510(k) K946144
K946144 is an FDA 510(k) premarket notification submitted by Clinical Controls, Inc. for the device "LIQUISPEX(TM) URINE ETHANOL CONTROL". The FDA issued a decision of Substantially Equivalent on Feb 8, 1995. The device falls under product code JJX (Single (Specified) Analyte Controls (Assayed And Unassayed)), a Class I device regulated under 21 CFR 862.1660. Clinical Controls, Inc. has 17 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 8, 1995
- Date Received
- Dec 16, 1994
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Single (Specified) Analyte Controls (Assayed And Unassayed)
- Device Class
- Class I
- Regulation Number
- 862.1660
- Review Panel
- CH
- Submission Type
- 510(k) Exempt