The following data is part of a premarket notification filed by Helena Laboratories with the FDA for Spife Lipporotein-12, Model 3344.
Device ID | K022333 |
510k Number | K022333 |
Device Name: | SPIFE LIPPOROTEIN-12, MODEL 3344 |
Classification | Electrophoretic Separation, Lipoproteins |
Applicant | HELENA LABORATORIES 1530 LINDBERGH DR. P.O. BOX 752 Beaumont, TX 77704 |
Contact | Patricia Franks |
Correspondent | Patricia 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 | 2002-07-18 |
Decision Date | 2002-08-15 |