The following data is part of a premarket notification filed by Dynatech Laboratories, Inc. with the FDA for Micro Elisa Mini Reader.
| Device ID | K800057 |
| 510k Number | K800057 |
| Device Name: | MICRO ELISA MINI READER |
| Classification | Colorimeter, Photometer, Spectrophotometer For Clinical Use |
| Applicant | DYNATECH LABORATORIES, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | JJQ |
| CFR Regulation Number | 862.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-01-10 |
| Decision Date | 1980-02-11 |