Atlas FDA

ACCU-CHECK COMBO SYSTEM

FDA 510(k) clearance K111353 · decided 2012-07-17

Clearance details

K-number
K111353
Device name
ACCU-CHECK COMBO SYSTEM
Applicant
Roche Diagnostics
Decision
Substantially Equivalent
Date received
2011-05-16
Decision date
2012-07-17
Days to decision
428 days
Clearance type
Abbreviated
Product code
LZG
Device class
2
Regulation number
880.5725
Medical specialty
General Hospital
Advisory committee
General Hospital
Location
Indianapolis, IN, US
Third-party review
No
Expedited review
No

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Recalls involving this device

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PMA approvals by this applicant

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Elecsys Anti-HBs II (P190034/S008)Roche Diagnostics2024-08-29
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