The following data is part of a premarket notification filed by Helena Laboratories with the FDA for Titan Gel High Resolution Serum Protein.
| Device ID | K821688 |
| 510k Number | K821688 |
| Device Name: | TITAN GEL HIGH RESOLUTION SERUM PROTEIN |
| Classification | Apparatus, Electrophoresis, For Clinical Use |
| Applicant | HELENA LABORATORIES 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JJN |
| CFR Regulation Number | 862.2485 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-06-08 |
| Decision Date | 1982-06-22 |