510(k) K932209
K932209 is an FDA 510(k) premarket notification submitted by Toxi-Lab, Inc. for the device "TOXI*LAB LTD OPIATE SYSTEM". The FDA issued a decision of Substantially Equivalent on September 24, 1993. The device falls under product code LAI (Thin Layer Chromatography, Opiates), a Class II device regulated under 21 CFR 862.3650. Toxi-Lab, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 24, 1993
- Date Received
- May 6, 1993
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Thin Layer Chromatography, Opiates
- Device Class
- Class II
- Regulation Number
- 862.3650
- Review Panel
- TX
- Submission Type