510(k) K880268
K880268 is an FDA 510(k) premarket notification submitted by Sigma Diagnostics, Inc. for the device "CO2 REAGENT". The FDA issued a decision of Substantially Equivalent on Mar 15, 1988. The device falls under product code KHS (Enzymatic, Carbon-Dioxide), a Class II device regulated under 21 CFR 862.1160. Sigma Diagnostics, Inc. has 163 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 15, 1988
- Date Received
- Jan 21, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Enzymatic, Carbon-Dioxide
- Device Class
- Class II
- Regulation Number
- 862.1160
- Review Panel
- CH
- Submission Type
- 510(k)