FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EDL ABNORMAL COAGULATION CONTROL
K Number: K891175
·
Decision Apr 10, 1989
Classifications
1
FEI Numbers
5
Registration Numbers
5
Same Product Code
7
Applicant Total
5
Review Days
35
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Basic Information
- Device Name
- EDL ABNORMAL COAGULATION CONTROL
- K Number
- K891175
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.8625
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Elite Diagnostic , Ltd.
- Date Received
- March 6, 1989
- Decision Date
- April 10, 1989
- Product Code
- GGL
- 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 |
|---|---|---|---|
| GGL | Control, White-Cell | FDA class 2 | Hematology |
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Other Clearances by Elite Diagnostic , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K890859 | EDL GLOBAL ACTIVATED PARTIAL THROMBOPLASTIN TIME | Apr 21, 1989 | Substantially Equivalent |
| K891370 | EDL ONE-STAGE PROTHROMBIN TIME REAGENT | Apr 21, 1989 | Substantially Equivalent |
| K891179 | EDL NORMAL COAGULATION CONTROL | Apr 10, 1989 | Substantially Equivalent |
| K890619 | EDL ACTIVATED PARTIAL THROMBOPLASTIN TIME REAGENT | Mar 15, 1989 | Substantially Equivalent |