FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
C-REACTIVE PROTEIN (LATEX) HIGH SENSITIVE TEST SYSTEM FOR COBAS INTEGRA INSTRUMENTS
K Number: K053603
·
Decision Feb 9, 2006
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
18
Applicant Total
264
Review Days
48
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
- C-REACTIVE PROTEIN (LATEX) HIGH SENSITIVE TEST SYSTEM FOR COBAS INTEGRA INSTRUMENTS
- K Number
- K053603
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5270
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Roche Diagnostics Corp.
- Date Received
- December 23, 2005
- Decision Date
- February 9, 2006
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (NQD), ordered by most recent decision date.
Tina-quant Cardiac high sensitivity CRP III
FDA 510(k)
FDA Class 2
·Immunology
Atellica® CH High Sensitivity C-Reactive Protein 2 (hCRP2)
FDA 510(k)
FDA Class 2
·Immunology
CardioPhase® hsCRP
FDA 510(k)
FDA Class 2
·Immunology
CRP Vario
FDA 510(k)
FDA Class 2
·Immunology
ADVIA CHEMISTRY CARDIOPHASE HIGH SENSITIVITY C-REACTIVE PROTEIN (HSCRP), CALIBRATORS
FDA 510(k)
FDA Class 2
·Immunology
IMMAGE IMMUNOCHEMISTRY SYSTEMS HIGH SENSITIVITY CARDIAC C-REACTIVE PROTEIN (CCRP) REAGENT
FDA 510(k)
FDA Class 2
·Immunology
Other Clearances by Roche Diagnostics Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K130138 | SUPER SANI-CLOTH/ ACCU-CHEK INFORM II SYSTEM | Mar 15, 2013 | Substantially Equivalent |
| K101365 | ELECSYS CA 19-9 CALCHECK 5 | Oct 5, 2010 | Substantially Equivalent |
| K100853 | COBAS 8000 MODULAR SERIES ANALYZER | Sep 9, 2010 | Substantially Equivalent |
| K101196 | ACCU-CHEK ULTRFLEX INFUSION SET | Aug 27, 2010 | Substantially Equivalent |
| K093664 | AMPHETAMINES II ASSAY | Jul 28, 2010 | Substantially Equivalent |
| K101075 | ELECSYS INSULIN CALCHECK 5 | Jun 11, 2010 | Substantially Equivalent |
| K093421 | ELECSYS TESTOSTERONE II IMMUNOASSAY | Apr 23, 2010 | Substantially Equivalent |
| K092848 | ELECSYS TROPONIN T CALCHECK 5 | Mar 19, 2010 | Substantially Equivalent |
| K092940 | COAGUCHEK XS PLUS PST SYSTEM | Mar 5, 2010 | Substantially Equivalent |
| K093700 | ELECSYS HCG STAT CALCHECK 5 | Mar 4, 2010 | Substantially Equivalent |