FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
URI-THREE(TM), MODIFICATION
K Number: K911846
·
Decision Oct 4, 1991
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
43
Applicant Total
9
Review Days
169
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- URI-THREE(TM), MODIFICATION
- K Number
- K911846
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2660
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Culture Kits, Inc.
- Date Received
- April 18, 1991
- Decision Date
- October 4, 1991
- 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.
OSMETECH MICROBIAL ANALYSER-URINARY TRACT INFECTION DETECTOR (OMA-UTI)
FDA 510(k)
FDA Class 1
·Microbiology
URISCREEN
FDA 510(k)
FDA Class 1
·Microbiology
URINE SCREENING DEVICE
FDA 510(k)
FDA Class 1
·Microbiology
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
Other Clearances by Culture Kits, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K854672 | CANDI-KIT TM | Jul 11, 1986 | Substantially Equivalent |
| K853488 | STAPH KIT | Aug 28, 1985 | Substantially Equivalent |
| K851225 | URINE DUO | Aug 13, 1985 | Substantially Equivalent |
| K852582 | GONI-KIT | Jul 12, 1985 | Substantially Equivalent |
| K852480 | DERM-KIT | Jul 9, 1985 | Substantially Equivalent |
| K851518 | MUELLER HINTON SENSITIVITY PLATE | Apr 29, 1985 | Substantially Equivalent |
| K850765 | STREP-KIT | Apr 24, 1985 | Substantially Equivalent |
| K850998 | URI-KIT | Apr 1, 1985 | Substantially Equivalent |