FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ACCU-CHEK CONNECT DIABETES MANAGEMENT APP
K Number: K141929
·
Decision Mar 16, 2015
Classifications
1
FEI Numbers
34
Registration Numbers
34
Same Product Code
54
Applicant Total
6
Review Days
243
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Basic Information
- Device Name
- ACCU-CHEK CONNECT DIABETES MANAGEMENT APP
- K Number
- K141929
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.1890
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Roche Diagnostics Corporation
- Date Received
- July 16, 2014
- Decision Date
- March 16, 2015
- Product Code
- NDC
- Advisory Committee
- Anesthesiology
- 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 |
|---|---|---|---|
| NDC | Calculator, Drug Dose | FDA class 2 | Anesthesiology |
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Other Clearances by Roche Diagnostics Corporation
| K Number | Device Name | ||
|---|---|---|---|
| K142089 | ACCU-CHEK AVIVA EXPERT SYSTEM | Dec 17, 2014 | Substantially Equivalent |
| K133862 | ACCU-CHEK AVIVA PLUS SYSTEM | Apr 29, 2014 | Substantially Equivalent |
| K112528 | ELECSYS T4 CALCHECK 5 | Oct 18, 2011 | Substantially Equivalent |
| K070172 | AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE | Apr 17, 2007 | Substantially Equivalent |
| K070174 | AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS; ROCHE SCRIPTS FOR CT/NG TEST ACCESSORY | Apr 16, 2007 | Substantially Equivalent |