The following data is part of a premarket notification filed by Helena Laboratories with the FDA for Spife Ld Vis Isoenzyme Kit, Models 3450, 3451, And 3452.
Device ID | K020467 |
510k Number | K020467 |
Device Name: | SPIFE LD VIS ISOENZYME KIT, MODELS 3450, 3451, AND 3452 |
Classification | Electrophoretic, Lactate Dehydrogenase Isoenzymes |
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 | CFE |
CFR Regulation Number | 862.1445 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-02-12 |
Decision Date | 2002-03-29 |