The following data is part of a premarket notification filed by Medi-tech, Inc. with the FDA for Coagulation Reference Plasma, Abnormal.
| Device ID | K904073 |
| 510k Number | K904073 |
| Device Name: | COAGULATION REFERENCE PLASMA, ABNORMAL |
| Classification | Control, Plasma, Abnormal |
| Applicant | MEDI-TECH, INC. 6020 NICOLLE ST. Ventura, CA 93003 |
| Contact | Michael Bick |
| Correspondent | Michael Bick MEDI-TECH, INC. 6020 NICOLLE ST. Ventura, CA 93003 |
| Product Code | GGC |
| CFR Regulation Number | 864.5425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-09-05 |
| Decision Date | 1990-10-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15391521421101 | K904073 | 000 |