The following data is part of a premarket notification filed by Corgenix, Inc. with the FDA for Reaads Anti-cardiolipin Igg/igm Semi-quantitative Test Kit, Model 023-001.
Device ID | K022992 |
510k Number | K022992 |
Device Name: | REAADS ANTI-CARDIOLIPIN IGG/IGM SEMI-QUANTITATIVE TEST KIT, MODEL 023-001 |
Classification | System, Test, Anticardiolipin Immunological |
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 | MID |
CFR Regulation Number | 866.5660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-09-09 |
Decision Date | 2002-09-25 |