FDA 510(k)
FDA class 1
Substantially Equivalent
🇬🇧 United Kingdom
OSMETECH MICROBIAL ANALYSER-URINARY TRACT INFECTION DETECTOR (OMA-UTI)
K Number: K011043
·
Decision Nov 30, 2001
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
43
Applicant Total
2
Review Days
239
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Basic Information
- Device Name
- OSMETECH MICROBIAL ANALYSER-URINARY TRACT INFECTION DETECTOR (OMA-UTI)
- K Number
- K011043
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2660
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Osmetech
- Date Received
- April 5, 2001
- Decision Date
- November 30, 2001
- 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.
URISCREEN
FDA 510(k)
FDA Class 1
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URINE SCREENING DEVICE
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FDA Class 1
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TRI-TECHIN. CUSTOM BLOOD AND/OR URINE TRANSPORT KIT
FDA 510(k)
FDA Class 1
·Microbiology
MULTIPLE (IZON DBS & URINE COLLECTION KIT)
FDA 510(k)
FDA Class 1
·Microbiology
MULTIPLE (IZON BLOOD & URINE COLLECTION KIT)
FDA 510(k)
FDA Class 1
·Microbiology
MULTIPLE (IZON URINE COLLECTION KIT)
FDA 510(k)
FDA Class 1
·Microbiology
Other Clearances by Osmetech
| K Number | Device Name | ||
|---|---|---|---|
| K023677 | OSMETECH MICROBIAL ANALYSER-BACTERIAL VAGINOSIS (OMA-BV) | Jan 29, 2003 | Substantially Equivalent |