FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ACCU-CHEK 360 DIABETES MANAGEMENT SYSTEM
K Number: K080227
·
Decision May 15, 2008
Classifications
1
FEI Numbers
37
Registration Numbers
37
Same Product Code
47
Applicant Total
264
Review Days
106
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Basic Information
- Device Name
- ACCU-CHEK 360 DIABETES MANAGEMENT SYSTEM
- K Number
- K080227
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 880.5725
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Roche Diagnostics Corp.
- Date Received
- January 30, 2008
- Decision Date
- May 15, 2008
- Product Code
- MRZ
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| MRZ | Accessories, Pump, Infusion | FDA class 2 | General Hospital |
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Other Clearances by Roche Diagnostics Corp.
| K Number | Device Name | ||
|---|---|---|---|
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| 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 |