The following data is part of a premarket notification filed by Corgenix, Inc. with the FDA for Reaads Igm Anti-prothrombin Semi-quantitative Test Kit.
Device ID | K001398 |
510k Number | K001398 |
Device Name: | REAADS IGM ANTI-PROTHROMBIN SEMI-QUANTITATIVE TEST KIT |
Classification | System, Test, Systemic Lupus Erythematosus |
Applicant | CORGENIX, INC. 12061 TEJON ST. Westminster, CO 80234 |
Contact | Nanci Dexter |
Correspondent | Nanci Dexter CORGENIX, INC. 12061 TEJON ST. Westminster, CO 80234 |
Product Code | DHC |
CFR Regulation Number | 866.5820 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-05-03 |
Decision Date | 2001-03-30 |