The following data is part of a premarket notification filed by Corgenix, Inc. with the FDA for Reaads Igm Anti-b2gp1 Test Kit.
Device ID | K982433 |
510k Number | K982433 |
Device Name: | REAADS IGM ANTI-B2GP1 TEST KIT |
Classification | System,test,antibodies,b2 - Glycoprotein I (b2 - Gpi) |
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 | MSV |
CFR Regulation Number | 866.5660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-07-14 |
Decision Date | 1998-12-07 |
Summary: | summary |