The following data is part of a premarket notification filed by Helena Laboratories with the FDA for Titan Gel Ife Antiserum To Igd-9409 & Ige-9410.
| Device ID | K872834 |
| 510k Number | K872834 |
| Device Name: | TITAN GEL IFE ANTISERUM TO IGD-9409 & IGE-9410 |
| Classification | Igd, 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 | CZJ |
| CFR Regulation Number | 866.5510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-07-17 |
| Decision Date | 1987-08-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M52594100 | K872834 | 000 |
| M52594200 | K872834 | 000 |
| M52594190 | K872834 | 000 |