The following data is part of a premarket notification filed by Helena Laboratories with the FDA for Titan Gel Rep Ldh-30 Hv.
| Device ID | K874142 |
| 510k Number | K874142 |
| Device Name: | TITAN GEL REP LDH-30 HV |
| Classification | Electrophoretic, Lactate Dehydrogenase Isoenzymes |
| Applicant | HELENA LABORATORIES 1530 LINDBERGH DR. P.O. BOX 752 Beaumont, TX 77704 |
| Contact | Eric Petersen |
| Correspondent | Eric Petersen HELENA LABORATORIES 1530 LINDBERGH DR. P.O. BOX 752 Beaumont, TX 77704 |
| Product Code | CFE |
| CFR Regulation Number | 862.1445 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-10-13 |
| Decision Date | 1987-11-24 |