The following data is part of a premarket notification filed by Dade, Baxter Travenol Diagnostics, Inc. with the FDA for Platelet Aggregating Reagents.
| Device ID | K780047 |
| 510k Number | K780047 |
| Device Name: | PLATELET AGGREGATING REAGENTS |
| Classification | System, Automated Platelet Aggregation |
| Applicant | DADE, BAXTER TRAVENOL DIAGNOSTICS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JOZ |
| CFR Regulation Number | 864.5700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-01-09 |
| Decision Date | 1978-03-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768003998 | K780047 | 000 |