FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODIFICATION TO TINA-QUANT D-DIMER TEST SYSTEM
K Number: K030740
·
Decision Apr 1, 2003
Classifications
1
FEI Numbers
22
Registration Numbers
22
Same Product Code
27
Applicant Total
264
Review Days
22
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
- MODIFICATION TO TINA-QUANT D-DIMER TEST SYSTEM
- K Number
- K030740
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 864.7320
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Roche Diagnostics Corp.
- Date Received
- March 10, 2003
- Decision Date
- April 1, 2003
- Product Code
- GHH
- Advisory Committee
- Hematology
- Review Advisory Committee
- HE
- 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 |
|---|---|---|---|
| GHH | Fibrin Split Products | FDA class 2 | Hematology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GHH), ordered by most recent decision date.
DIAZYME D-DIMER ASSAY KIT,CALIBRATOR SETAND CONTROL SET
FDA 510(k)
FDA Class 2
·Hematology
PATHFAST D-DIMER
FDA 510(k)
FDA Class 2
·Hematology
OLYMPUS D-DIMER REAGENT, MODEL OSR6X135, OLYMPUS D-DIMER CALIBRATOR, MODEL ODR3033, OLYMPUS D-DIMER CONTROL
FDA 510(k)
FDA Class 2
·Hematology
TINA-QUANT D-DIMER TEST SYSTEM
FDA 510(k)
FDA Class 2
·Hematology
TRIAGE D-DIMER TEST, MODEL 98100
FDA 510(k)
FDA Class 2
·Hematology
MDA D-DIMER
FDA 510(k)
FDA Class 2
·Hematology
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 |