510(k) K863423
K863423 is an FDA 510(k) premarket notification submitted by Plastic Injectors, Inc. for the device "CODE-A-WELL SERIES 1-1000 AND SERIES 1-1100". The FDA issued a decision of Substantially Equivalent on September 16, 1986. The device falls under product code JTC (Device, Microtiter Diluting/Dispensing), a Class I device regulated under 21 CFR 866.2500. Plastic Injectors, Inc. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 16, 1986
- Date Received
- September 4, 1986
- 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