The following data is part of a premarket notification filed by Helena Laboratories with the FDA for Rep Hdl/ldl-30 Kit - Cat. No. 3220,3221,3222.
| Device ID | K940679 |
| 510k Number | K940679 |
| Device Name: | REP HDL/LDL-30 KIT - CAT. NO. 3220,3221,3222 |
| Classification | Electrophoretic Separation, Lipoproteins |
| 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 | JHO |
| CFR Regulation Number | 862.1475 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-02-09 |
| Decision Date | 1994-09-09 |