The following data is part of a premarket notification filed by Dynatech Laboratories, Inc. with the FDA for Mr 700 Microplate Reader 012-700-1000.
| Device ID | K854303 |
| 510k Number | K854303 |
| Device Name: | MR 700 MICROPLATE READER 012-700-1000 |
| Classification | Colorimeter, Photometer, Spectrophotometer For Clinical Use |
| Applicant | DYNATECH LABORATORIES, INC. 900 SLATERS LN. Alexandria, VA 22314 |
| Contact | Heidi E Chandonnet |
| Correspondent | Heidi E Chandonnet DYNATECH LABORATORIES, INC. 900 SLATERS LN. Alexandria, VA 22314 |
| Product Code | JJQ |
| CFR Regulation Number | 862.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-10-25 |
| Decision Date | 1985-11-19 |