The following data is part of a premarket notification filed by Corgenix, Inc. with the FDA for Reaads Von Willebrand Factor Activity Test Kit, Model 10826.
Device ID | K032139 |
510k Number | K032139 |
Device Name: | REAADS VON WILLEBRAND FACTOR ACTIVITY TEST KIT, MODEL 10826 |
Classification | Test, Qualitative And Quantitative Factor Deficiency |
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 | GGP |
CFR Regulation Number | 864.7290 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-07-11 |
Decision Date | 2004-04-05 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00855360006267 | K032139 | 000 |