The following data is part of a premarket notification filed by Helena Laboratories with the FDA for Spife Urine Ife.
| Device ID | K982639 |
| 510k Number | K982639 |
| Device Name: | SPIFE URINE IFE |
| Classification | Igm (mu Chain Specific), Antigen, Antiserum, Control |
| 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 | DAO |
| CFR Regulation Number | 866.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-07-29 |
| Decision Date | 1998-11-04 |