The following data is part of a premarket notification filed by Helena Laboratories with the FDA for Rep(r) Spe Template 30, 16, & 8.
| Device ID | K913807 |
| 510k Number | K913807 |
| Device Name: | REP(R) SPE TEMPLATE 30, 16, & 8 |
| Classification | Electrophoretic, Protein Fractionation |
| 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 | CEF |
| CFR Regulation Number | 862.1630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-08-26 |
| Decision Date | 1991-11-27 |