The following data is part of a premarket notification filed by Medical Diagnostic Technologies, Inc. with the FDA for Platelet Aggregation Reagents.
| Device ID | K910286 |
| 510k Number | K910286 |
| Device Name: | PLATELET AGGREGATION REAGENTS |
| Classification | Reagent, Platelet Aggregation |
| 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 | GHR |
| CFR Regulation Number | 864.5700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-01-22 |
| Decision Date | 1991-03-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15391521420067 | K910286 | 000 |