The following data is part of a premarket notification filed by Helena Laboratories with the FDA for Platelet Aggregation Reagent Set.
| Device ID | K832428 |
| 510k Number | K832428 |
| Device Name: | PLATELET AGGREGATION REAGENT SET |
| Classification | Reagent, Platelet Aggregation |
| Applicant | HELENA LABORATORIES 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GHR |
| CFR Regulation Number | 864.5700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-07-22 |
| Decision Date | 1983-10-20 |