Atlas FDA

ACCU-CHEK COMFORT CURVE TEST STRIP

FDA 510(k) clearance K010362 · decided 2001-03-07

Clearance details

K-number
K010362
Device name
ACCU-CHEK COMFORT CURVE TEST STRIP
Applicant
Roche Diagnostics Corp.
Decision
Substantially Equivalent
Date received
2001-02-06
Decision date
2001-03-07
Days to decision
29 days
Clearance type
Special
Product code
LFR
Device class
2
Regulation number
862.1345
Medical specialty
Clinical Chemistry
Advisory committee
Clinical Chemistry
Location
Indianapolis, IN, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Accu-Chek Comfort Curve blood glucose test strips; (packaged in 10s, 50s, and/or 100s) U.S recall (Z-1377-06)Roche Diagnostics Corp.2006-08-11
Accu-Chek Comfort Curve blood glucose test strips; Reference numbers 12030420001, 12030373 recall (Z-0566-06)Roche Diagnostics Corp.2006-02-28
Accu-Chek Sensor Comfort blood glucose test strips; Reference numbers 03261956170, 0326196 recall (Z-0571-06)Roche Diagnostics Corp.2006-02-28
Accu-Chek Sensor Comfort Pro blood glucose test strips; Reference numbers 0375877001, 0336 recall (Z-0572-06)Roche Diagnostics Corp.2006-02-28
Accu-Chek Inform blood glucose test strips; Reference numbers 04535057001, 04647696001 and recall (Z-0573-06)Roche Diagnostics Corp.2006-02-28
Accu-Chek Comfort Curve glucose test strips; part numbers 2030420, 2030365, 2030373, 20303 recall (Z-0715-03)Roche Diagnostics Corp.2003-04-09

PMA approvals by this applicant

RecordFirmDate
ELECSYS FREE PSA IMMUNOASSAY/CALSET/CALCHECK (P000027/S043)Roche Diagnostics Corp.2025-05-27
ELECSYS TOTAL PSA IMMUNOASSAY AND TOTAL PSA CALSET (P990056/S044)Roche Diagnostics Corp.2025-05-27
Elecsys Anti-HBc II (P100031/S033)Roche Diagnostics Corp.2025-05-22
Elecsys Anti-HBc II (P100032/S023)Roche Diagnostics Corp.2025-05-22
Elecsys Anti-HBc IgM (P110031/S027)Roche Diagnostics Corp.2025-05-22
Elecsys Anti-HBc IgM (P110022/S034)Roche Diagnostics Corp.2025-05-22
Elecsys Anti-HBs (P010054/S048)Roche Diagnostics Corp.2025-05-22
Elecsys Anti-HBc IgM and PreciControl Anti-HBc IgM (P110031/S025)Roche Diagnostics Corp.2024-11-22