The following data is part of a premarket notification filed by Astral Medical Systems with the FDA for Electrophoresis Apparatus, For Clinical Use 160,18.
| Device ID | K851154 |
| 510k Number | K851154 |
| Device Name: | ELECTROPHORESIS APPARATUS, FOR CLINICAL USE 160,18 |
| Classification | Densitometer/scanner (integrating, Reflectance, Tlc, Radiochromat.) Clinica |
| Applicant | ASTRAL MEDICAL SYSTEMS 6900 ORANGETHORPE AVE. Buena Park, CA 90620 |
| Contact | Thad Morris |
| Correspondent | Thad Morris ASTRAL MEDICAL SYSTEMS 6900 ORANGETHORPE AVE. Buena Park, CA 90620 |
| Product Code | JQT |
| CFR Regulation Number | 862.2400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-03-22 |
| Decision Date | 1985-05-13 |