The following data is part of a premarket notification filed by Dynatech Laboratories, Inc. with the FDA for Mr 650 Microplate Reader(cat. No. 011-973-0500).
| Device ID | K852411 |
| 510k Number | K852411 |
| Device Name: | MR 650 MICROPLATE READER(CAT. NO. 011-973-0500) |
| Classification | Colorimeter, Photometer, Spectrophotometer For Clinical Use |
| Applicant | DYNATECH LABORATORIES, INC. 900 SLATERS LN. Alexandria, VA 22314 |
| Contact | Richard K Prescott |
| Correspondent | Richard K Prescott 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 | 1985-06-06 |
| Decision Date | 1985-09-30 |