AUTOHDL CHOLESTEROL REAGENT SET— 510(k) K992002
Substantially EquivalentPointe Scientific, Inc.,
FDA 510(k) clearance K992002 for AUTOHDL CHOLESTEROL REAGENT SET, Substantially Equivalent on 1999-08-05. Applicant: Pointe Scientific, Inc.,. Device class: 1.
Clearance details
- Applicant
- Pointe Scientific, Inc.,
- Product code
- Code LBR
- Device class
- Class 1
- Regulation
- 21 CFR 862.1475
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Lincoln Park, MI, US
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- K012593 — VITROS CHEMISTRY PRODUCTS MAGNETIC HDL-CHOLESTEROL REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 2
More clearances from Pointe Scientific, Inc.,
view allRecalls naming K992002
K-number listed on FDA's recall record- Z-0389-2019 — 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 plasma. For in vitro diagnostic use only.
- Z-2764-2015 — 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 3x14 ml of R2 HDL600 kit includes 3x40 ml of R1 and 3x14 ml of R2 Kits: HDPE plastic bottle, PP plastic caps. Bulk: PE plastic cube containers, PP plastic caps. Quantitative determination of high density lipoprotein cholesterol in human serum or plasma. In vitro diagnostic use only.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K992002.
Data sourced from openFDA. This site is unofficial and independent of the FDA.