FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ACTICLOT PROTEIN S, MODEL 843L
K Number: K012386
·
Decision Sep 14, 2001
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
189
Applicant Total
10
Review Days
49
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Basic Information
- Device Name
- ACTICLOT PROTEIN S, MODEL 843L
- K Number
- K012386
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.7290
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- American Diagnostica, Inc.
- Date Received
- July 27, 2001
- Decision Date
- September 14, 2001
- Product Code
- GGP
- 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 |
|---|---|---|---|
| GGP | Test, Qualitative And Quantitative Factor Deficiency | FDA class 2 | Hematology |
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Other Clearances by American Diagnostica, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K080069 | DIMERTEST | Feb 13, 2008 | Substantially Equivalent |
| K063323 | SPECTROLYSE PAI-1, MODEL 101201 | Aug 15, 2007 | Substantially Equivalent |
| K052124 | ACTICLOT, MODEL 824 | Oct 17, 2005 | Substantially Equivalent |
| K013637 | ACTICHROME HEPARIN (ANTI-FIIA) | Apr 16, 2002 | Substantially Equivalent |
| K013492 | IMUBIND TPA ELISA, MODEL 860 | Mar 13, 2002 | Substantially Equivalent |
| K013318 | ACTICHROME HEPARIN (ANTI-FXA), MODEL 832 | Mar 8, 2002 | Substantially Equivalent |
| K013168 | IMUBIND PLASMA PAI-1 ELISA,MODEL 822 | Mar 7, 2002 | Substantially Equivalent |
| K940490 | DV TEST AND DVV CONFIRM | Apr 5, 1995 | Substantially Equivalent |
| K935254 | DVVTEST AND DVVCONFIRM LUPUS ANTICOAGULANT NORMAL AND ABNORMAL CONTROL PLASMA | Sep 19, 1994 | Substantially Equivalent |