The following data is part of a premarket notification filed by Astral Medical Systems with the FDA for Coatron F(same As Coatron, But Also Does Fibrinoge.
| Device ID | K851153 |
| 510k Number | K851153 |
| Device Name: | COATRON F(SAME AS COATRON, BUT ALSO DOES FIBRINOGE |
| Classification | System, Multipurpose For In Vitro Coagulation Studies |
| 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 | JPA |
| CFR Regulation Number | 864.5425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-03-22 |
| Decision Date | 1985-11-05 |