The following data is part of a premarket notification filed by Radiological Engineering, Inc. with the FDA for Mst-1050-ii X-ray Unit.
| Device ID | K853210 |
| 510k Number | K853210 |
| Device Name: | MST-1050-II X-RAY UNIT |
| Classification | Slide Stainer, Automated |
| Applicant | RADIOLOGICAL ENGINEERING, INC. 2160 LITTLETON RD. North Ft. Myers, FL 33903 |
| Contact | Ralph L Frizzle |
| Correspondent | Ralph L Frizzle RADIOLOGICAL ENGINEERING, INC. 2160 LITTLETON RD. North Ft. Myers, FL 33903 |
| Product Code | KPA |
| CFR Regulation Number | 864.3800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-07-31 |
| Decision Date | 1985-10-10 |