FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RAPET CRP
K Number: K974429
·
Decision Feb 18, 1998
Classifications
1
FEI Numbers
33
Registration Numbers
33
Same Product Code
69
Applicant Total
47
Review Days
86
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
- RAPET CRP
- K Number
- K974429
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5270
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Stanbio Laboratory
- Date Received
- November 24, 1997
- Decision Date
- February 18, 1998
- Product Code
- DCN
- 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 |
|---|---|---|---|
| DCN | System, Test, C-Reactive Protein | FDA class 2 | Immunology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DCN), ordered by most recent decision date.
CardioPhase® hsCRP
FDA 510(k)
FDA Class 2
·Immunology
RCRP Flex reagent cartridge
FDA 510(k)
FDA Class 2
·Immunology
Tina-quant C-Reactive Protein IV
FDA 510(k)
FDA Class 2
·Immunology
Optilite High Sensitivity C-Reactive Protein Kit
FDA 510(k)
FDA Class 2
·Immunology
Optilite C-Reactive Protein Reagent,Optilite C-Reactive Protein Calibrator,Optilite C-Reactive Protein Controls
FDA 510(k)
FDA Class 2
·Immunology
MSD CRP Assay Kit and MESO SECTOR S 700 Instrument
FDA 510(k)
FDA Class 2
·Immunology
Other Clearances by Stanbio Laboratory
| K Number | Device Name | ||
|---|---|---|---|
| K090093 | STANBIO LABORATORY HEMOPOINT H2 DM HEMOGLOBIN MEASUREMENT SYSTEM | Jun 10, 2009 | Substantially Equivalent |
| K081719 | STANBIO LABORATORY HEMOPOINT H2 HEMOGLOBIN MEASUREMENT SYSTEM | Jul 18, 2008 | Substantially Equivalent |
| K050266 | DIRECT BILIRUBIN LIQUICOLOR AND TOTAL BILIRUBIN LIQUICOLOR | Jun 30, 2005 | Substantially Equivalent |
| K050283 | CREATININE LIQUICOLOR | Jun 30, 2005 | Substantially Equivalent |
| K042169 | STANBIO LABORATORY SIRRUS CLINICAL CHEMISTRY ANALYZER | Mar 14, 2005 | Substantially Equivalent |
| K041155 | WIDE RANGE C-REACTIVE PROTEIN (WR CRP) ASSAY | Oct 14, 2004 | Substantially Equivalent |
| K032936 | DIRECT LDL CHOLESTEROL LIQUID COLOR AND STANBIO DIRECT HDL/LDL CHOLESTEROL CALIBRATOR | Mar 12, 2004 | Substantially Equivalent |
| K032932 | DIRECT HDL-CHOLESTEROL LIQUID COLOR; DIRECT HDL/LDL-CHOLESTEROL CALIBRATOR | Mar 10, 2004 | Substantially Equivalent |
| K032482 | STANBIO LABORATORY HEMOPOINT H2 HEMOGLOBIN MEASUREMENT SYSTEM | Oct 24, 2003 | Substantially Equivalent |
| K020378 | QUPID PLUS E.R. | Jun 21, 2002 | Substantially Equivalent |