Atlas FDA

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

FDA 510(k) clearance K012286 · decided 2001-08-08

Clearance details

K-number
K012286
Device name
MODIFICATION TO:COBAS INTEGRA HDL-CHOLESTEROL PLUS 2ND GENERATION
Applicant
Roche Diagnostics Corp.
Decision
Substantially Equivalent
Date received
2001-07-20
Decision date
2001-08-08
Days to decision
19 days
Clearance type
Special
Product code
LBS
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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EASYRA HDL REAGENT; EASYRA LDL REAGENT; EASYRA CHOL REAGENT; EASYRA TRIG REAGENT (K111036)Medica Corporation2011-07-12
POLY-CHEM 90 DIRECT HDL CHOLESTEROL, POLY-CHEM 90 DIRECT LDL CHOLESTEROL, POLY-CHEM 90 CHOLESTEROL, POLY-CHEM 90 TRIGLYC (K100550)Polymedco, Inc.2010-09-28
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APOLOWAKO T-CHO, HDL-C, TG AND ANALYZER, MODELS 993-23501, 999-23601, 995-23701 AND 993-25201 (K080125)Wako Chemicals USA, Inc.2008-07-18
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Recalls involving this device

RecordFirmDate
HDL-Cholesterol plus gen.3.; and Small Supersized Intended for use on COBAS Integra 800 an recall (Z-1925-2015)Roche Diagnostics Operations, Inc.2015-06-27
Roche Diagnostics HDLC3, HDL-Cholesterol Plus 3rd Generation, COBAS INTEGRA, cobas c syste recall (Z-0010-2009)Roche Diagnostics Corp.2008-10-09

PMA approvals by this applicant

RecordFirmDate
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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