The following data is part of a premarket notification filed by Plastic Injectors, Inc. with the FDA for Code-a-well 350 Microtitration Strips.
| Device ID | K842848 |
| 510k Number | K842848 |
| Device Name: | CODE-A-WELL 350 MICROTITRATION STRIPS |
| Classification | Device, Microtiter Diluting/dispensing |
| Applicant | PLASTIC INJECTORS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JTC |
| CFR Regulation Number | 866.2500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-07-20 |
| Decision Date | 1984-09-07 |