FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
K-ASSAY D-DIMER, K-ASSAY D-DIMER CALIBRATOR, MODELS KAI-090; KAJ-091C
K Number: K030687
·
Decision Jun 27, 2003
Classifications
1
FEI Numbers
28
Registration Numbers
28
Same Product Code
56
Applicant Total
43
Review Days
114
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
- K-ASSAY D-DIMER, K-ASSAY D-DIMER CALIBRATOR, MODELS KAI-090; KAJ-091C
- K Number
- K030687
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.7320
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Kamiya Biomedical Co.
- Date Received
- March 5, 2003
- Decision Date
- June 27, 2003
- Product Code
- DAP
- 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 |
|---|---|---|---|
| DAP | Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control | FDA class 2 | Hematology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DAP), ordered by most recent decision date.
HemosIL D-Dimer HS 500
FDA 510(k)
FDA Class 2
·Hematology
STA® - Liatest® D-Di
FDA 510(k)
FDA Class 2
·Hematology
HemosIL D-Dimer HS
FDA 510(k)
FDA Class 2
·Hematology
HemosIL D-Dimer HS
FDA 510(k)
FDA Class 2
·Hematology
STA LIATEST D-DI
FDA 510(k)
FDA Class 2
·Hematology
VIDAS D-DIMER EXCLUSION II (DEX2)
FDA 510(k)
FDA Class 2
·Hematology
Other Clearances by Kamiya Biomedical Co.
| K Number | Device Name | ||
|---|---|---|---|
| K093137 | K-ASSAY CYSTATIN C REAGENT, CALIBRATOR AND CONTROL | Sep 28, 2010 | Substantially Equivalent |
| K091486 | K-ASSAY MICROALBUMIN AND K-ASSAY MICROALBUMIN CALIBRATOR | Apr 29, 2010 | Substantially Equivalent |
| K050944 | K-ASSAY FERRITIN (2) & FERRITIN CALIBRATOR SET | Dec 23, 2005 | Substantially Equivalent |
| K042241 | K-ASSAY TOTAL IGE, K-ASSAY IGE CALIBRATOR SET, MODELS KAI-092/KAI-093C | Dec 10, 2004 | Substantially Equivalent |
| K023828 | K-ASSAY C-REACTIVE PROTEIN (3), K-ASSAY CRP MULTI-CALIBRATOR D, K-ASSAY CRP MULTI-CALIBRATOR E, K-ASSAY CRP MULTI-CALIBR | Feb 4, 2003 | Substantially Equivalent |
| K023853 | K-ASSAY LP(A) CONTROLS | Dec 13, 2002 | Substantially Equivalent |
| K022486 | K-ASSAY HS-CRP CONTROLS | Aug 14, 2002 | Substantially Equivalent |
| K021660 | K-ASSAY LP(A) ASSAY | Jul 25, 2002 | Substantially Equivalent |
| K014293 | K-ASSAY FERRITIN, K-ASSAY FERRITIN CALIBRATOR SET | Feb 19, 2002 | Substantially Equivalent |
| K012422 | K-ASSAY D-DIMER CONTROLS | Aug 21, 2001 | Substantially Equivalent |