The following data is part of a premarket notification filed by Medical Diagnostic Technologies, Inc. with the FDA for Coagulation Reference Plasma, Normal.
| Device ID | K905203 |
| 510k Number | K905203 |
| Device Name: | COAGULATION REFERENCE PLASMA, NORMAL |
| Classification | Plasma, Control, Normal |
| Applicant | MEDICAL DIAGNOSTIC TECHNOLOGIES, INC. 6020 NICOLLE ST., STE. D Ventura, CA 93003 |
| Contact | Michael D Bick |
| Correspondent | Michael D Bick MEDICAL DIAGNOSTIC TECHNOLOGIES, INC. 6020 NICOLLE ST., STE. D Ventura, CA 93003 |
| Product Code | GIZ |
| CFR Regulation Number | 864.5425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-11-20 |
| Decision Date | 1990-12-28 |