The following data is part of a premarket notification filed by Helena Laboratories with the FDA for Spife 3000 Titan Gel Igg Ief Kit, Model 3389.
Device ID | K024162 |
510k Number | K024162 |
Device Name: | SPIFE 3000 TITAN GEL IGG IEF KIT, MODEL 3389 |
Classification | Immunoelectrophoretic, Immunoglobulins, (g, A, M) |
Applicant | HELENA LABORATORIES 1530 LINDBERGH DR. P.O. BOX 752 Beaumont, TX 77704 |
Contact | Eric Petersen |
Correspondent | Eric Petersen HELENA LABORATORIES 1530 LINDBERGH DR. P.O. BOX 752 Beaumont, TX 77704 |
Product Code | CFF |
CFR Regulation Number | 866.5510 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-12-17 |
Decision Date | 2003-02-19 |