FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AUTOMARQER
K Number: K990184
·
Decision Mar 19, 1999
Classifications
1
FEI Numbers
13
Registration Numbers
13
Same Product Code
27
Applicant Total
5
Review Days
58
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Basic Information
- Device Name
- AUTOMARQER
- K Number
- K990184
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.5220
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Hamilton Thorne Research
- Date Received
- January 20, 1999
- Decision Date
- March 19, 1999
- Product Code
- POV
- 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 |
|---|---|---|---|
| POV | Semen Analysis Device | FDA class 2 | Hematology |
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