Atlas FDA

AUTOHDL CHOLESTEROL REAGENT SET

FDA 510(k) clearance K992002 · decided 1999-08-05

Clearance details

K-number
K992002
Device name
AUTOHDL CHOLESTEROL REAGENT SET
Applicant
Pointe Scientific, Inc.,
Decision
Substantially Equivalent
Date received
1999-06-15
Decision date
1999-08-05
Days to decision
51 days
Clearance type
Traditional
Product code
LBR
Device class
1
Regulation number
862.1475
Medical specialty
Clinical Chemistry
Advisory committee
Clinical Chemistry
Location
Lincoln Park, MI, US
Third-party review
No
Expedited review
No

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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
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
BOEHRINGER MANNHEIM DIRECT LDL - CHOLESTEROL (K974733)Boehringer Mannheim Corp.1998-01-26

Recalls involving this device

RecordFirmDate
Pointe Scientific autoHDL Reagent H7545 H7545-R1 in a bulk cube container or HDPE plastic recall (Z-2764-2015)Pointe Scientific, Inc.2015-09-14
Pointe Scientific Liquid Auto HDL Cholesterol Reagent Set, Pointe Scientific, Inc., Canton recall (Z-1200-2009)Pointe Scientific, Inc.2009-04-27
Pointe Scientific Liquid Auto HDL Cholesterol Reagent Set, Pointe Scientific, Inc., Canton recall (Z-1201-2009)Pointe Scientific, Inc.2009-04-27
Stanbio Laboratory Direct HDL Cholesterol LiquiColor, Catalog #0590-040; test kit contains recall (Z-0074-2007)Stanbio Laboratory, Inc2006-11-14
Stanbio Laboratory Direct HDL Cholesterol LiquiColor, Catalog #0590-080; test kit contains recall (Z-0075-2007)Stanbio Laboratory, Inc2006-11-14
Stanbio Laboratory SIRRUS Direct HDL Cholesterol LiquiColor, Catalog #S0590-540; kit conta recall (Z-0076-2007)Stanbio Laboratory, Inc2006-11-14
Liquid AutoHDL Cholesterol Reagent Set, Manufactured for Pointe Scientific, Inc.; Catalog recall (Z-1454-06)Pointe Scientific, Inc.2006-08-30
AutoHDL Cholesterol Reagent Set for the quantitative determination of high density lipopro recall (Z-1455-06)Pointe Scientific, Inc.2006-08-30
AutoHDL Cholesterol R1 Reagent Set, a homogeneous method for the direct determination of h recall (Z-1456-06)Pointe Scientific, Inc.2006-08-30
AutoHDL Cholesterol R2 Reagent Set, a homogeneous method for the direct determination of h recall (Z-1457-06)Pointe Scientific, Inc.2006-08-30
Auto HDL reagent, sold by Pointe Scientific; Catalog no. 3-H7545-L . recall (Z-1458-06)Pointe Scientific, Inc.2006-08-30
Auto HDL Cholesterol reagent in bottles of 320 ml and 1000 ml, sold by Pointe Scientific; recall (Z-1459-06)Pointe Scientific, Inc.2006-08-30