FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HUMAN IGG SUBCLASS LIQUID REAGENT KITS FOR USE ON THE SPAPLUS ANALYSER
K Number: K072889
·
Decision Feb 1, 2008
Classifications
1
FEI Numbers
20
Registration Numbers
20
Same Product Code
60
Applicant Total
115
Review Days
114
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- HUMAN IGG SUBCLASS LIQUID REAGENT KITS FOR USE ON THE SPAPLUS ANALYSER
- K Number
- K072889
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5510
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- The Binding Site, Ltd.
- Date Received
- October 10, 2007
- Decision Date
- February 1, 2008
- Product Code
- CFN
- 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 |
|---|---|---|---|
| CFN | Method, Nephelometric, Immunoglobulins (G, A, M) | FDA class 2 | Immunology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CFN), ordered by most recent decision date.
N Antisera to Human Immunoglobulins (IgG, IgA, and IgM)
FDA 510(k)
FDA Class 2
·Immunology
Immunoglobulin G (IgG)
FDA 510(k)
FDA Class 2
·Immunology
Human IgA liquid reagent kit for Use on SPAPlus
FDA 510(k)
FDA Class 2
·Immunology
Optilite IgA Kit
FDA 510(k)
FDA Class 2
·Immunology
Optilite IgM Kit
FDA 510(k)
FDA Class 2
·Immunology
Human IgM Kit for use on SPAPlus
FDA 510(k)
FDA Class 2
·Immunology
Other Clearances by The Binding Site, Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K231290 | Optilite® Freelite® Kappa Free Kit, Optilite® Freelite® Lambda Free Kit | Jan 24, 2024 | Substantially Equivalent |
| K090920 | HUMAN IGG SUBCLASS LIQUID REAGENT KITS (FOR USE ON HITACHI 911/ 912/ 917 AND MODULAR P) | Dec 30, 2009 | Substantially Equivalent |
| K083289 | HUMAN BETA-2 MICROGLOBULIN KIT | May 6, 2009 | Substantially Equivalent |
| K082129 | HUMAN IGM LIQUID REAGENT KIT FOR USE ON THE SPAPLUS ANALYZER | Feb 10, 2009 | Substantially Equivalent |
| K081827 | HUMAN IGA LIQUID REAGENT KIT FOR USE ON SPAPLUS | Dec 19, 2008 | Substantially Equivalent |
| K081674 | BINDAZYME HUMAN ANTI-GLIADIN (MGP), IGG EIA KIT; BINDAZYME HUMAN ANTI-GLIADIN (MGP) IGA EIA KIT; (IGA OR IGG) | Oct 15, 2008 | Substantially Equivalent |
| K080384 | HUMAN CYSTATIN C KIT FOR USE ON MODULAR P ANALYSER | Jun 6, 2008 | Substantially Equivalent |
| K070900 | FREELITE HUMAN KAPPA AND LAMBDA FREE DIAGNOSTIC TEST KITS FOR USE ON THE ROCHE COBAS INTEGRA 400/400 PLUS ANALYZER KIT | Nov 30, 2007 | Substantially Equivalent |
| K062372 | FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE SPAPLUS ANALYZER | Jun 21, 2007 | Substantially Equivalent |
| K062183 | FARRZYME HUMAN HIGH AVIDITY ANTI-DSDNA ENZYME IMMUNOASSAY KIT | Nov 21, 2006 | Substantially Equivalent |