The following data is part of a premarket notification filed by Medical Diagnostic Technologies, Inc. with the FDA for Abnormal Reference Plasma-ix.
| Device ID | K895504 |
| 510k Number | K895504 |
| Device Name: | ABNORMAL REFERENCE PLASMA-IX |
| Classification | Plasma, Coagulation Factor Deficient |
| Applicant | MEDICAL DIAGNOSTIC TECHNOLOGIES, INC. 6020 NICOLLE ST., STE. D Ventura, CA 93003 |
| Contact | Bick, Phd |
| Correspondent | Bick, Phd MEDICAL DIAGNOSTIC TECHNOLOGIES, INC. 6020 NICOLLE ST., STE. D Ventura, CA 93003 |
| Product Code | GJT |
| CFR Regulation Number | 864.7290 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-09-12 |
| Decision Date | 1989-10-06 |