The following data is part of a premarket notification filed by Helena Laboratories with the FDA for Rep Cholesterol Profile Control.
| Device ID | K950590 |
| 510k Number | K950590 |
| Device Name: | REP CHOLESTEROL PROFILE CONTROL |
| Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
| 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 | JJX |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-02-09 |
| Decision Date | 1995-03-30 |