The following data is part of a premarket notification filed by Helena Laboratories with the FDA for Packs-4 (tm) Analyzer.
| Device ID | K912201 |
| 510k Number | K912201 |
| Device Name: | PACKS-4 (TM) ANALYZER |
| Classification | Aggregometer, Platelet, Photo-optical Scanning |
| Applicant | HELENA LABORATORIES 1530 LINDBERGH DR. P.O. BOX 752 Beaumont, TX 77704 |
| Contact | Pat Franks |
| Correspondent | Pat Franks HELENA LABORATORIES 1530 LINDBERGH DR. P.O. BOX 752 Beaumont, TX 77704 |
| Product Code | JBY |
| CFR Regulation Number | 864.6675 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-05-20 |
| Decision Date | 1991-08-16 |