The following data is part of a premarket notification filed by Plastic Injectors, Inc. with the FDA for Code-a-well Series 1-1000 And Series 1-1100.
| Device ID | K863423 |
| 510k Number | K863423 |
| Device Name: | CODE-A-WELL SERIES 1-1000 AND SERIES 1-1100 |
| Classification | Device, Microtiter Diluting/dispensing |
| Applicant | PLASTIC INJECTORS, INC. P.O. BOX 188 Spartanburg, SC 29304 |
| Contact | William R Fulton |
| Correspondent | William R Fulton PLASTIC INJECTORS, INC. P.O. BOX 188 Spartanburg, SC 29304 |
| Product Code | JTC |
| CFR Regulation Number | 866.2500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-09-04 |
| Decision Date | 1986-09-16 |