The following data is part of a premarket notification filed by Helena Laboratories with the FDA for Free Protein S Reagent Cat. No. 5363.
| Device ID | K904247 |
| 510k Number | K904247 |
| Device Name: | FREE PROTEIN S REAGENT CAT. NO. 5363 |
| Classification | Test, Qualitative And Quantitative Factor Deficiency |
| 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 | GGP |
| CFR Regulation Number | 864.7290 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-09-14 |
| Decision Date | 1991-01-18 |