The following data is part of a premarket notification filed by Helena Laboratories with the FDA for Rep Direct-sep Cholesterol-15 Kit; Cholesterol-8 Kit; Cholesterol-4 Kit.
Device ID | K935162 |
510k Number | K935162 |
Device Name: | REP DIRECT-SEP CHOLESTEROL-15 KIT; CHOLESTEROL-8 KIT; CHOLESTEROL-4 KIT |
Classification | Electrophoretic Separation, Lipoproteins |
Applicant | HELENA LABORATORIES P.O. BOX 752 1530 LINDBERGH DRIVE Beaumont, TX 77704 |
Contact | Pat Franks |
Correspondent | Pat Franks HELENA LABORATORIES P.O. BOX 752 1530 LINDBERGH DRIVE 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 | 1993-10-29 |
Decision Date | 1994-11-10 |