The following data is part of a premarket notification filed by Helena Laboratories with the FDA for Protein C Antigen Rocket Eid Method No. 5357.
| Device ID | K897136 |
| 510k Number | K897136 |
| Device Name: | PROTEIN C ANTIGEN ROCKET EID METHOD NO. 5357 |
| 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 | 1989-12-27 |
| Decision Date | 1990-02-05 |