Panels › Clinical Chemistry › Product code LBR · Class 1
Ldl & Vldl Precipitation, Hdl
Regulation 862.1475
0510(k)s in 12 months (66 all time)
0recalls in 12 months (11 all time)
10recalls that name a 510(k)
Top companies in LBR
| Company | 510(k)s | Recalls |
|---|---|---|
| Pointe Scientific, Inc., | 3 | 5 |
| Diagnostic Chemicals , Ltd. | 3 | 0 |
| Genzyme Corp. | 3 | 0 |
| Merchant House Scientific | 3 | 0 |
| Stanbio Laboratory, Inc | 0 | 3 |
| American Monitor Corp. | 2 | 0 |
| Boehringer Mannheim Corp. | 2 | 0 |
| Ortho-Clinical Diagnostics, Inc. | 2 | 0 |
| Preventive Diagnostics Corp. | 2 | 0 |
| Reference Diagnostics, Inc. | 2 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 10, 2018 | Medtest 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 |
LBR | K992002 |
| Dec 29, 2016 | Sterling Diagnostics, Inc. Sterling Diagnostics, Inc., HDL Cholesterol (PEF Method) for IN VITRO DIAGNOSTIC USE in the quantitative determination of analytes. These are CONSUMABLES - a customer buys another when kit is consumed Terminated |
LBR | None listed |
| Sep 14, 2015 | Pointe 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 |
LBR | K992002 |
| Jun 27, 2015 | Roche Diagnostics Operations, Inc. LDL-Cholesterol plus gen.2.
The Boehringer Mannheim Direct LDL-Cholesterol test in intended for the quantitative determination of low-density lipoprotein Cholesterol (LDL-C) in serum and plasma. Terminated |
LBR | K974733 |
| Feb 25, 2010 | Pointe Scientific, Inc. Liquid HDL (PEG) Cholesterol Reagent, Pointe Scientific, Inc, Canton, MI; Catalog # 7-H7511-30, 8-H7511-30, 3-H-7511-L. (Clinical chemistry).
For the quantitative determination of high density lipopr Terminated |
LBR | K812574 |
| Feb 25, 2010 | Pointe Scientific, Inc. Liquid HDL (PEG) Cholesterol Reagent Set. Pointe Scientific HDL Cholesterol Reagent Set, Pointe Scientific, Inc, Canton, MI; Catalog # H7511-60 and Catalog # H7511-SAM. HDL Cholesterol Reagent Set, Terminated |
LBR | K812574 |
| Apr 27, 2009 | Pointe 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 |
LBR | K992002 |
| Apr 27, 2009 | Pointe 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 |
LBR | K992002 |
| Nov 14, 2006 | Stanbio 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 |
LBR | K992002 |
| Nov 14, 2006 | Stanbio 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 |
LBR | K992002 |
| Nov 14, 2006 | Stanbio 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 |
LBR | K992002 |
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