FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
URISCREEN
K Number: K981084
·
Decision Oct 7, 1998
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
43
Applicant Total
1
Review Days
196
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Basic Information
- Device Name
- URISCREEN
- K Number
- K981084
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2660
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Diatech Diagnostics,Inc.
- Date Received
- March 25, 1998
- Decision Date
- October 7, 1998
- Product Code
- JXA
- Advisory Committee
- Microbiology
- Review Advisory Committee
- MI
- 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 |
|---|---|---|---|
| JXA | Kit, Screening, Urine | FDA class 1 | Microbiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JXA), ordered by most recent decision date.
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