510(k) K913737
K913737 is an FDA 510(k) premarket notification submitted by Instrumentation Laboratory CO for the device "IL TEST(TM) COCAINE". The FDA issued a decision of Substantially Equivalent on December 3, 1991. The device falls under product code JXO (Enzyme Immunoassay, Cocaine), a Class II device regulated under 21 CFR 862.3250. Instrumentation Laboratory CO has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 3, 1991
- Date Received
- August 20, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Enzyme Immunoassay, Cocaine
- Device Class
- Class II
- Regulation Number
- 862.3250
- Review Panel
- TX
- Submission Type