FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ROCHE DIAGNOSTICS URISYS 1100 URINE ANALYZER
K Number: K033548
·
Decision Nov 24, 2003
Classifications
1
FEI Numbers
62
Registration Numbers
62
Same Product Code
96
Applicant Total
264
Review Days
12
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
- ROCHE DIAGNOSTICS URISYS 1100 URINE ANALYZER
- K Number
- K033548
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 864.6550
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Roche Diagnostics Corp.
- Date Received
- November 12, 2003
- Decision Date
- November 24, 2003
- Product Code
- KHE
- Advisory Committee
- Hematology
- Review Advisory Committee
- CH
- 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 |
|---|---|---|---|
| KHE | Reagent, Occult Blood | FDA class 2 | Hematology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KHE), ordered by most recent decision date.
Instant-view-PLUS immunochemical Fecal Occult Blood Test
FDA 510(k)
FDA Class 2
·Hematology
InSure ONE
FDA 510(k)
FDA Class 2
·Hematology
hema-screen SPECIFIC Gold
FDA 510(k)
FDA Class 2
·Hematology
Wondfo One Step Fecal Occult Blood (FOB) Test
FDA 510(k)
FDA Class 2
·Hematology
hema-screen ER XCEL Enhanced Readability Fecal Occult Blood Test
FDA 510(k)
FDA Class 2
·Hematology
OC-Light S FIT
FDA 510(k)
FDA Class 2
·Hematology
Other Clearances by Roche Diagnostics Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K130138 | SUPER SANI-CLOTH/ ACCU-CHEK INFORM II SYSTEM | Mar 15, 2013 | Substantially Equivalent |
| K101365 | ELECSYS CA 19-9 CALCHECK 5 | Oct 5, 2010 | Substantially Equivalent |
| K100853 | COBAS 8000 MODULAR SERIES ANALYZER | Sep 9, 2010 | Substantially Equivalent |
| K101196 | ACCU-CHEK ULTRFLEX INFUSION SET | Aug 27, 2010 | Substantially Equivalent |
| K093664 | AMPHETAMINES II ASSAY | Jul 28, 2010 | Substantially Equivalent |
| K101075 | ELECSYS INSULIN CALCHECK 5 | Jun 11, 2010 | Substantially Equivalent |
| K093421 | ELECSYS TESTOSTERONE II IMMUNOASSAY | Apr 23, 2010 | Substantially Equivalent |
| K092848 | ELECSYS TROPONIN T CALCHECK 5 | Mar 19, 2010 | Substantially Equivalent |
| K092940 | COAGUCHEK XS PLUS PST SYSTEM | Mar 5, 2010 | Substantially Equivalent |
| K093700 | ELECSYS HCG STAT CALCHECK 5 | Mar 4, 2010 | Substantially Equivalent |