FDA 510(k)
FDA class 2
Substantially Equivalent
🇯🇵 Japan
LP(A)-LATEX SEIKEN ASSAY KIT
K Number: K013359
·
Decision Mar 8, 2002
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
42
Applicant Total
4
Review Days
149
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
- LP(A)-LATEX SEIKEN ASSAY KIT
- K Number
- K013359
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5600
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Denka Seiken'S
- Date Received
- October 10, 2001
- Decision Date
- March 8, 2002
- Product Code
- DFC
- 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 |
|---|---|---|---|
| DFC | Lipoprotein, Low-Density, Antigen, Antiserum, Control | FDA class 2 | Immunology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DFC), ordered by most recent decision date.
Lipoprotein (a) Molarity Assay
FDA 510(k)
FDA Class 2
·Immunology
Tina-quant Lipoprotein(a) Gen.2 Molarity
FDA 510(k)
FDA Class 2
·Immunology
Lp(a) Ultra
FDA 510(k)
FDA Class 2
·Immunology
Diazyme Lipoprotein (a) Assay
FDA 510(k)
FDA Class 2
·Immunology
ADVIA CHEMISTRY LIPOPROTEIN(A) REAGENT ADVIA CHEMISTRY LIPOPROTEIN(A) CALIBRATOR
FDA 510(k)
FDA Class 2
·Immunology
COBAS C TINA-QUANT LIPOPROTEIN (A) GEN 2 ASSAY MODEL 05852625190; PRECISET LP (A) GEN 2 CALIFRATOR SET MODEL 05852641160
FDA 510(k)
FDA Class 2
·Immunology