Atlas FDA

Accu-Chek FlexLink Plus infusion set

FDA 510(k) clearance K143446 · decided 2015-08-13

Clearance details

K-number
K143446
Device name
Accu-Chek FlexLink Plus infusion set
Applicant
Roche Diagnostics GmbH
Decision
Substantially Equivalent
Date received
2014-12-02
Decision date
2015-08-13
Days to decision
254 days
Clearance type
Traditional
Product code
FPA
Device class
2
Regulation number
880.5440
Medical specialty
General Hospital
Advisory committee
General Hospital
Location
Mannheim, DE
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
CEA-ROCHE(R) EIA (P840027/S005)Roche Diagnostics GmbH1989-05-01
CEA-ROCHE(R) EIA (P840027/S006)Roche Diagnostics GmbH1989-05-01
CEA-ROCHE(R) EIA (P840027/S004)Roche Diagnostics GmbH1988-11-29
CEA-ROCHE(R) EIA (P840027/S003)Roche Diagnostics GmbH1988-07-07
CEA-ROCHE(R) EIA (P840027/S002)Roche Diagnostics GmbH1987-02-19
CEA-ROCHE(R) EIA (P840027/S001)Roche Diagnostics GmbH1986-09-08
COBAS BACT (P840065)Roche Diagnostics GmbH1986-05-30
CEA-ROCHE(R) EIA (P840027)Roche Diagnostics GmbH1985-05-13