510(k) K823137
K823137 is an FDA 510(k) premarket notification submitted by Corning Costar Corp. for the device "OCTAPETTES". The FDA issued a decision of Substantially Equivalent on December 3, 1982. The device falls under product code JTC (Device, Microtiter Diluting/Dispensing), a Class I device regulated under 21 CFR 866.2500. Corning Costar Corp. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 3, 1982
- Date Received
- October 25, 1982
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Device, Microtiter Diluting/Dispensing
- Device Class
- Class I
- Regulation Number
- 866.2500
- Review Panel
- MI
- Submission Type