FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
IMMULITE 2500 HIGH SENSITIVITY C-REACTIVE PROTEIN, MODELS L5KCRP (200 TESTS), L5KCRP (600 TESTS)
K Number: K071017
·
Decision May 2, 2007
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
18
Applicant Total
11
Review Days
22
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Basic Information
- Device Name
- IMMULITE 2500 HIGH SENSITIVITY C-REACTIVE PROTEIN, MODELS L5KCRP (200 TESTS), L5KCRP (600 TESTS)
- K Number
- K071017
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 866.5270
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Siemens Medical Solutions Diagnostics
- Date Received
- April 10, 2007
- Decision Date
- May 2, 2007
- Product Code
- NQD
- Advisory Committee
- Immunology
- 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 |
|---|---|---|---|
| NQD | Cardiac C-Reactive Protein, Antigen, Antiserum, And Control | FDA class 2 | Immunology |
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| K Number | Device Name | ||
|---|---|---|---|
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| K091984 | IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT, MODEL L2KUN6 | Oct 28, 2009 | Substantially Equivalent |
| K081895 | ADVIA CHEMISTRY HEMOGLOBIN A1C, ADVIA CHEMISTRY A1C CALIBRATORS | Jan 8, 2009 | Substantially Equivalent |
| K071455 | ADVIA CENTAUR CYCLOSPORINE ASSAY AND CALIBRATOR | Sep 11, 2008 | Substantially Equivalent |
| K073537 | NEONATAL BILIRUBIN ON RAPIDLAB MODELS 1245 AND 1265 | Jun 27, 2008 | Substantially Equivalent |
| K072658 | ADVIA CHEMISTRY C-REACTIVE PROTEIN_2, (CRP_2) AND CALIBRATORS | Apr 1, 2008 | Substantially Equivalent |
| K072794 | IMMULITE 2500 OM-MA, MODEL L5KOP | Nov 5, 2007 | Substantially Equivalent |
| K071466 | DCA VANTAGE, MODEL 5075 | Oct 9, 2007 | Substantially Equivalent |
| K072204 | ADVIA CHEMISTRY MICROALBUMIN CALIBRATORS, _2 CALIBRATORS | Oct 5, 2007 | Substantially Equivalent |
| K070727 | ADVIA CHEMISTRY ENZYMATIC CREATININE_2 | Aug 3, 2007 | Substantially Equivalent |