510(k) K863203
K863203 is an FDA 510(k) premarket notification submitted by Sigma Diagnostics, Inc. for the device "CHOLINESTERASE (BTC) REAGENT". The FDA issued a decision of Substantially Equivalent on Sep 17, 1986. The device falls under product code DIH (Colorimetry, Cholinesterase), a Class I device regulated under 21 CFR 862.3240. Sigma Diagnostics, Inc. has 163 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 17, 1986
- Date Received
- Aug 19, 1986
- 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
- 510(k) Exempt