FDA 510(k)
FDA class 2
Substantially Equivalent
🇬🇧 United Kingdom
AXIS-SHIELD LIQUID STABLE (LS) 2-PART HOMOCYSTEINE REAGENT, MODEL FHRK100
K Number: K083222
·
Decision Jul 31, 2009
Classifications
1
FEI Numbers
28
Registration Numbers
28
Same Product Code
28
Applicant Total
24
Review Days
270
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Basic Information
- Device Name
- AXIS-SHIELD LIQUID STABLE (LS) 2-PART HOMOCYSTEINE REAGENT, MODEL FHRK100
- K Number
- K083222
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1377
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Axis-Shield Diagnostics, Ltd.
- Date Received
- November 3, 2008
- Decision Date
- July 31, 2009
- Product Code
- LPS
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- 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 |
|---|---|---|---|
| LPS | Urinary Homocystine (Nonquantitative) Test System | FDA class 2 | Clinical Chemistry |
Similar 510(k) Clearances
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Other Clearances by Axis-Shield Diagnostics, Ltd.
| K Number | Device Name | ||
|---|---|---|---|
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| K241176 | Alere NT-proBNP for Alinity i Reagent Kit | Jan 16, 2025 | Substantially Equivalent |
| K233541 | ARCHITECT Active-B12 (Holotranscobalamin) | Jul 31, 2024 | Substantially Equivalent |
| K172133 | ADVIA Centaur Active-B12 (Holotranscobalamin) (AB12) Assay | Oct 27, 2017 | Substantially Equivalent |
| K121946 | AXIS-SHIELD ACVTIVE-B12 | Mar 22, 2013 | Substantially Equivalent |
| K121842 | ARCHITECT HBA1C, ARCHITECT HBA1C, AND ARCHITECT HBA1C | Dec 12, 2012 | Substantially Equivalent |
| K112790 | AXIS-SHIELD 3-REAGENT HOMOCYSTEINE ASSAY FOR SYNCHRON | May 7, 2012 | Substantially Equivalent |
| K112443 | ARCHITECT ACTIVE B-12 (HOLOTRANSCOBALAMIN) | Dec 19, 2011 | Substantially Equivalent |
| K110296 | AXIS-SHIELD ANTI-CCP | Aug 18, 2011 | Substantially Equivalent |
| K083868 | ARCHITECT ANTI-CCP (100 TEST), ARCHITECT ANTI-CCP (500 TEST), MODELS 1P65-25, 1P65-35 | Sep 25, 2009 | Substantially Equivalent |