The following data is part of a premarket notification filed by Helena Laboratories with the FDA for Plateletworks Arachidonic Acid, Model Pw-aca.
| Device ID | K061991 |
| 510k Number | K061991 |
| Device Name: | PLATELETWORKS ARACHIDONIC ACID, MODEL PW-ACA |
| Classification | Reagent, Platelet Aggregation |
| Applicant | HELENA LABORATORIES P.O. BOX 752 1530 LINDBERGH DRIVE Beaumont, TX 77704 |
| Contact | Patricia Franks |
| Correspondent | Patricia Franks HELENA LABORATORIES P.O. BOX 752 1530 LINDBERGH DRIVE Beaumont, TX 77704 |
| Product Code | GHR |
| CFR Regulation Number | 864.5700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-07-13 |
| Decision Date | 2007-02-23 |