Atlas FDA

N-GENEOUS HDL CHOLESTEROL KIT/CHOLESTEROL CALIBRATOR

FDA 510(k) clearance K962186 · decided 1996-08-19

Clearance details

K-number
K962186
Device name
N-GENEOUS HDL CHOLESTEROL KIT/CHOLESTEROL CALIBRATOR
Applicant
Genzyme Corp.
Decision
Substantially Equivalent
Date received
1996-06-06
Decision date
1996-08-19
Days to decision
74 days
Clearance type
Traditional
Product code
LBR
Device class
1
Regulation number
862.1475
Medical specialty
Clinical Chemistry
Advisory committee
Clinical Chemistry
Location
Cambridge, MA, US
Third-party review
No
Expedited review
No

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Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
LDLC3 LDL-Cholesterol Gen.3 (K143691)Roche Diagnostics Operations (Rdo)2015-01-28
DIAZYME LDL-CHOLESTEROL REAGENT, CALIBRATOR AND CONTROLS (K072523)General Atomics2008-01-22
DIRECT HDL CHOLESTEROL AND DIRECT HDL/LDL CALIBRATOR (K050823)Teco Diagnostics2005-07-26
RAICHEM HDL CHOLESTEROL USING CANTROL HDL PRECIPITATING TUBES ON THE COBAS MIRA ANAYLZER (K023784)Hemagen Diagnostics, Inc.2002-12-24
VITROS CHEMISTRY PRODUCTS MAGNETIC HDL-CHOLESTEROL REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 2 (K012593)Ortho-Clinical Diagnostics, Inc.2001-08-30
ATAC DIRECT HDL CHOLESTEROL REAGENT AND ATAC HDL-C CALIBRATOR KITS (K992029)Elan Diagnostics1999-08-12
AUTOHDL CHOLESTEROL REAGENT SET (K992002)Pointe Scientific, Inc.,1999-08-05
ATAC-PAK DIRECT HDL CHOLESTEROL REAGENT AND ATAC HDL-C CALIBRATOR KITS (K991789)Elan Holdings, Inc.1999-07-09
MTM BIOSCANNER HDL, MODEL # BSA450, BSA460, BSA470 (K990247)Polymer Technology Systems, Inc.1999-05-28
VITROS CHEMISTRY PRODUCTS MAGNETIC HDL-CHOLESTEROL REAGENT (K984303)Ortho-Clinical Diagnostics, Inc.1999-01-28
HDL-CHOLESTEROL PRECIPITATING REAGENT, CATALOGUE NUMBER 205-51 (K980772)Diagnostic Chemicals , Ltd.1998-04-27
HDL UNI-PAKS (PTA), CATALOGUE NUMBER 215-51 (K980770)Diagnostic Chemicals , Ltd.1998-04-21

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
LEGOO (P110003/S004)Genzyme Corp.2014-03-26
LEGOO (P110003/S003)Genzyme Corp.2012-11-13
LEGOO ENDOVASCULAR OCCLUSION GEL (P110003/S002)Genzyme Corp.2012-11-13
LEGOO ENDOVASCULAR OCCLUDER (P110003/S001)Genzyme Corp.2012-03-01
LEGOO (P110003)Genzyme Corp.2011-09-28
FOCALSEAL-L SYNTHETIC ABSORBABLE SEALANT (P990028/S007)Genzyme Corp.2003-12-04
FOCALSEAL-L SYNTHETIC ABSORBABLE SEALANT (P990028/S006)Genzyme Corp.2003-02-04
FOCALSEAL-L SYNTHETIC ABSORBABLE SEALANT (P990028/S005)Genzyme Corp.2002-11-25