Atlas FDA

MODIFICATION TO: COBAS INTEGRA LDL-CHOLESTEROL PLUS 2ND GENERATION

FDA 510(k) clearance K012287 · decided 2001-08-07

Clearance details

K-number
K012287
Device name
MODIFICATION TO: COBAS INTEGRA LDL-CHOLESTEROL PLUS 2ND GENERATION
Applicant
Roche Diagnostics Corp.
Decision
Substantially Equivalent
Date received
2001-07-20
Decision date
2001-08-07
Days to decision
18 days
Clearance type
Special
Product code
MRR
Device class
1
Regulation number
862.1475
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
LDL-Cholesterol gen.2. The Boehringer Mannheim Direct LDL-Cholesterol test in intended for recall (Z-1927-2015)Roche Diagnostics Operations, Inc.2015-06-27
Roche Diagnostics LDL_C, LDL- Cholesterol Plus 2nd generation, COBAS INTEGRA, cobas c syst recall (Z-0006-2009)Roche Diagnostics Corp.2008-10-09

PMA approvals by this applicant

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