FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CHEMSTRIP 5 OB, CHEMSTRIP 7 AND CHEMSTRIP 10 MD TEST STRIPS
K Number: K032437
·
Decision Oct 8, 2003
Classifications
1
FEI Numbers
52
Registration Numbers
52
Same Product Code
80
Applicant Total
264
Review Days
62
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
- CHEMSTRIP 5 OB, CHEMSTRIP 7 AND CHEMSTRIP 10 MD TEST STRIPS
- K Number
- K032437
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1340
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Roche Diagnostics Corp.
- Date Received
- August 7, 2003
- Decision Date
- October 8, 2003
- Product Code
- JIL
- Advisory Committee
- Clinical Chemistry
- 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 |
|---|---|---|---|
| JIL | Method, Enzymatic, Glucose (Urinary, Non-Quantitative) | FDA class 2 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JIL), ordered by most recent decision date.
AUTION MAX AX-4060 Urinalysis System
FDA 510(k)
FDA Class 2
·Clinical Chemistry
cobas u 601 urinalysis test system
FDA 510(k)
FDA Class 2
·Clinical Chemistry
DIP/U.S. Urine Analysis Test System
FDA 510(k)
FDA Class 2
·Clinical Chemistry
inui In-Home Urine Analysis Test System
FDA 510(k)
FDA Class 2
·Clinical Chemistry
DUS 2GP Reagent Strips, DUS 5 Reagent Strips, DUS 10 Reagent Strips
FDA 510(k)
FDA Class 2
·Clinical Chemistry
DUS R-50S (Urine Chemistry system)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
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 |