The following data is part of a premarket notification filed by Helena Laboratories with the FDA for Electrophoresis Work Center (ewc).
| Device ID | K861414 |
| 510k Number | K861414 |
| Device Name: | ELECTROPHORESIS WORK CENTER (EWC) |
| Classification | Apparatus, Electrophoresis, For Clinical Use |
| 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 | JJN |
| CFR Regulation Number | 862.2485 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-04-15 |
| Decision Date | 1986-08-26 |