The following data is part of a premarket notification filed by Medical Diagnostic Technologies, Inc. with the FDA for Factor Xi Deficient Plasma.
| Device ID | K893536 |
| 510k Number | K893536 |
| Device Name: | FACTOR XI DEFICIENT PLASMA |
| 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 | 1989-05-08 |
| Decision Date | 1989-06-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15391521420432 | K893536 | 000 |