ClearanceBrief
510(k) K992002 ยท LBR Ldl & Vldl Precipitation, Hdl

AUTOHDL CHOLESTEROL REAGENT SET

ApplicantPointe Scientific, Inc.,, Lincoln Park MI, US
DecisionSubstantially Equivalent, Aug 5, 1999
ReceivedJun 15, 1999
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K992002

DateFirm and productCodeLinked 510(k)
Aug 10, 2018Medtest Holdings, Inc.
Pointe Scientific AutoHDL/LDL Cholesterol Calibrator, Catalog Number H7545-CAL - Product Usage: For the calibration of Pointe Scientific s autoHDL and autoLDL Cholesterol Reagent Set in serum or plasm
Terminated		 LBRNone listed
Sep 14, 2015Pointe Scientific, Inc.
Pointe Scientific autoHDL Reagent H7545 H7545-R1 in a bulk cube container or HDPE plastic bottle H7545-1000 kit includes 1x750 ml of R1 and 1x250 ml of R2 12-H7545-162 kit includes 3x40 ml of R1 and
Terminated		 LBRNone listed
Apr 27, 2009Pointe Scientific, Inc.
Pointe Scientific Liquid Auto HDL Cholesterol Reagent Set, Pointe Scientific, Inc., Canton, MI, Catalog Numbers: 10-H7545-80, 12-H7545-162, 3-H7545-L, 7-H7545-1000, 7-H7545-320, 7-H7545-40, 7-H7545-8
Terminated		 LBRNone listed
Apr 27, 2009Pointe Scientific, Inc.
Pointe Scientific Liquid Auto HDL Cholesterol Reagent Set, Pointe Scientific, Inc., Canton, MI, Catalog Numbers: 10-H7545-80, 12-H7545-162, 3-H7545-L, 7-H7545-1000, 7-H7545-320, 7-H7545-40, 7-H7545-8
Terminated		 LBRNone listed
Nov 14, 2006Stanbio Laboratory, Inc
Stanbio Laboratory Direct HDL Cholesterol LiquiColor, Catalog #0590-040; test kit contains 1/30mL container of Direct HDL-Cholesterol Buffer (R1) and 1/10mL container of Direct HDL-Cholesterol Enzyme
Terminated		 LBRNone listed
Nov 14, 2006Stanbio Laboratory, Inc
Stanbio Laboratory Direct HDL Cholesterol LiquiColor, Catalog #0590-080; test kit contains 2/30mL container of Direct HDL-Cholesterol Buffer (R1) and 2/10mL container of Direct HDL-Cholesterol Enzyme
Terminated		 LBRNone listed
Nov 14, 2006Stanbio Laboratory, Inc
Stanbio Laboratory SIRRUS Direct HDL Cholesterol LiquiColor, Catalog #S0590-540; kit contains 6 x 90 tests, HDL Buffer (R1) and HDL Enzyme (R2); in vitro diagnostic distributed by Stanbio Laboratory,
Terminated		 LBRNone listed
Aug 30, 2006Pointe Scientific, Inc.
Liquid AutoHDL Cholesterol Reagent Set, Manufactured for Pointe Scientific, Inc.; Catalog Nos. HH945-240, HH945-480, H7545-40, H7545-80, H7545-320 and H7545-1000. A homogeneous method for the direct
Terminated		 CCHNone listed
Aug 30, 2006Pointe Scientific, Inc.
AutoHDL Cholesterol Reagent Set for the quantitative determination of high density lipoprotein (HDL) cholesterol in serum or plasma, Imported and Marketed in India by Ranbaxy Fine Chemicals Ltd.; Cat
Terminated		 CCHNone listed
Aug 30, 2006Pointe Scientific, Inc.
AutoHDL Cholesterol R1 Reagent Set, a homogeneous method for the direct determination of high density lipoprotein (HDL) cholesterol in serum or plasma, Manufactured for Pointe Scientific, Inc.; Catal
Terminated		 CCHNone listed
Aug 30, 2006Pointe Scientific, Inc.
AutoHDL Cholesterol R2 Reagent Set, a homogeneous method for the direct determination of high density lipoprotein (HDL) cholesterol in serum or plasma, Manufactured for Pointe Scientific, Inc.; Catal
Terminated		 CCHNone listed
Aug 30, 2006Pointe Scientific, Inc.
Auto HDL reagent, sold by Pointe Scientific; Catalog no. 3-H7545-L .
Terminated		 CCHNone listed
Aug 30, 2006Pointe Scientific, Inc.
Auto HDL Cholesterol reagent in bottles of 320 ml and 1000 ml, sold by Pointe Scientific; Catalog nos. 7-H7545-320 and 7-H7545-1000.
Terminated		 CCHNone listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.