The following data is part of a premarket notification filed by Medical Diagnostic Technologies, Inc. with the FDA for La Positive Control Plasma.
| Device ID | K961370 |
| 510k Number | K961370 |
| Device Name: | LA POSITIVE CONTROL PLASMA |
| Classification | Control, Plasma, Abnormal |
| Applicant | MEDICAL DIAGNOSTIC TECHNOLOGIES, INC. 6025 NICOLLE ST. Ventura, CA 93003 |
| Contact | Michael D Bick, Ph.d. |
| Correspondent | Michael D Bick, Ph.d. MEDICAL DIAGNOSTIC TECHNOLOGIES, INC. 6025 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 | 1996-04-09 |
| Decision Date | 1996-05-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15391521420661 | K961370 | 000 |