FDA 510(k)
FDA class 2
Substantially Equivalent
🇦🇺 Australia
DIMERTEST LATEX ASSAY
K Number: K974596
·
Decision May 26, 1998
Classifications
1
FEI Numbers
28
Registration Numbers
28
Same Product Code
56
Applicant Total
6
Review Days
168
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Basic Information
- Device Name
- DIMERTEST LATEX ASSAY
- K Number
- K974596
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.7320
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Agen Biomedical , Ltd.
- Date Received
- December 9, 1997
- Decision Date
- May 26, 1998
- 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 |
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Other Clearances by Agen Biomedical , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K993276 | SIMPLIFY D-DIMER, MODEL DCGK1 | Dec 14, 1999 | Substantially Equivalent |
| K945642 | AGEN DIMERTEST GOLD EIA | Oct 25, 1995 | Substantially Equivalent |
| K905643 | BED RED D-DIMER WHOLE BLOOD AGGLUTINATION ASSAY | Apr 12, 1991 | Substantially Equivalent |
| K890189 | AGEN DIMERTEST EIA | Mar 3, 1989 | Substantially Equivalent |
| K882944 | DIMERTEST(R) LATEX | Aug 17, 1988 | Substantially Equivalent |