FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DVVTEST AND DVVCONFIRM LUPUS ANTICOAGULANT NORMAL AND ABNORMAL CONTROL PLASMA
K Number: K935254
·
Decision Sep 19, 1994
Classifications
1
FEI Numbers
15
Registration Numbers
15
Same Product Code
19
Applicant Total
10
Review Days
322
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Basic Information
- Device Name
- DVVTEST AND DVVCONFIRM LUPUS ANTICOAGULANT NORMAL AND ABNORMAL CONTROL PLASMA
- K Number
- K935254
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.5425
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- American Diagnostica, Inc.
- Date Received
- November 1, 1993
- Decision Date
- September 19, 1994
- Product Code
- GIZ
- 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 |
|---|---|---|---|
| GIZ | Plasma, Control, Normal | FDA class 2 | Hematology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GIZ), ordered by most recent decision date.
STASIS - I, II AND III; SERATHAN - A, B; INTRIN - EA, SI CALCIUM CHLORIDE 0.02M; FIBRINOGEN CONTROL-NORMAL, LOW
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ACCUCLOT CONTROL I, MODEL A4089
FDA 510(k)
FDA Class 2
·Hematology
CONTROL PLASMA N
FDA 510(k)
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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 |
| K012386 | ACTICLOT PROTEIN S, MODEL 843L | Sep 14, 2001 | Substantially Equivalent |
| K940490 | DV TEST AND DVV CONFIRM | Apr 5, 1995 | Substantially Equivalent |