510(k) K012907
K012907 is an FDA 510(k) premarket notification submitted by Clinical Controls for the device "LIQUISPX LIQUID SALIVA OR UNRINE DRUG OF ABUSE CONTROL". The FDA issued a decision of Substantially Equivalent on Sep 28, 2001. The device falls under product code DIF (Drug Mixture Control Materials), a Class I device regulated under 21 CFR 862.3280. Clinical Controls has 17 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 28, 2001
- Date Received
- Aug 29, 2001
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Drug Mixture Control Materials
- Device Class
- Class I
- Regulation Number
- 862.3280
- Review Panel
- TX
- Submission Type
- 510(k) Exempt