FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
REAADS ANTI-BETA 2 GLYCOPROTEIN I IGG TEST KIT
K Number: K013080
·
Decision Sep 28, 2001
Classifications
1
FEI Numbers
19
Registration Numbers
19
Same Product Code
45
Applicant Total
23
Review Days
14
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Basic Information
- Device Name
- REAADS ANTI-BETA 2 GLYCOPROTEIN I IGG TEST KIT
- K Number
- K013080
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 866.5660
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Corgenix, Inc.
- Date Received
- September 14, 2001
- Decision Date
- September 28, 2001
- Product Code
- MSV
- Advisory Committee
- Immunology
- Review Advisory Committee
- IM
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MSV | System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi) | FDA class 2 | Immunology |
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Other Clearances by Corgenix, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K072032 | IGG ANTI-ATHEROX TEST KIT | Apr 4, 2008 | Substantially Equivalent |
| K062025 | ASPIRINWORKS TEST KIT (11-DEHYDRO THROMBOXANE B2), MODEL 12136 | May 29, 2007 | Substantially Equivalent |
| K042680 | RHIGENE HEP-ANA TEST SYSTEM | Nov 19, 2004 | Substantially Equivalent |
| K032139 | REAADS VON WILLEBRAND FACTOR ACTIVITY TEST KIT, MODEL 10826 | Apr 5, 2004 | Substantially Equivalent |
| K034013 | REAADS DSDNA QUANTITATIVE TEST KIT, MODEL 022-001 | Jan 8, 2004 | Substantially Equivalent |
| K032868 | REAADS II ANTI-CARDIOLIPIN IGG SEMI-QUANTITATIVE TEST KIT, MODEL 11139 | Oct 14, 2003 | Substantially Equivalent |
| K031208 | REAADS IGM ANTI-B2GPI TEST KIT, MODEL 038-001 | Jul 7, 2003 | Substantially Equivalent |
| K024196 | REEADS ANTI-PHOSPHATIDYLSERINE IGG/IGM SEMI-QUANTITATIVE TEST KIT | Jan 3, 2003 | Substantially Equivalent |
| K024195 | MODIFICATION TO REAADS ANTI-PHOSPHATIDYLSERINE IGA SEMI-QUANTATIVE TEST KIT | Jan 3, 2003 | Substantially Equivalent |
| K022990 | REAADS IGA ANTI-CARDIOLIPIN SEMI-QUANTITATIVE TEST KIT, MODEL 026-001 | Sep 25, 2002 | Substantially Equivalent |