510(k) K943367
K943367 is an FDA 510(k) premarket notification submitted by Instrumentation Laboratory CO for the device "IL TEST CHOLINESTERASE". The FDA issued a decision of Substantially Equivalent on February 5, 1996. The device falls under product code DIH (Colorimetry, Cholinesterase), a Class I device regulated under 21 CFR 862.3240. Instrumentation Laboratory CO has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 5, 1996
- Date Received
- July 13, 1994
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Colorimetry, Cholinesterase
- Device Class
- Class I
- Regulation Number
- 862.3240
- Review Panel
- TX
- Submission Type