Pointe Scientific, Inc.,
Pointe Scientific, Inc., holds FDA 510(k) medical device clearances, first cleared 1981, most recent 2007, with 3 FDA device recalls on record.
Top product codes for Pointe Scientific, Inc.,
FDA recalls by Pointe Scientific, Inc.,
- Z-2487-2015 — Pointe Scientific G6PD Controls Kit configuration: 6 x 0.5 ml (2 vials each of Level 1, Level 2 and Level 3). Also sold as individual vials Bottle: Clear glass vials Cap: Rubber seal with colored aluminum seals Glucose-6-phosphate dehydrogenase (G6PD) controls can be used to test for the quantitative and qualitative determination of G6PD in blood.
- 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.
- Z-2773-2015 — Pointe Scientific Creatinine Reagent Catalog number C7539-150 in vitro diagnostic C7539-150 kit includes one R1 and one R2 bottle. R1: HDPE plastic bottle. 120 ml fill. R2: HDPE plastic bottle. 90 ml fill.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Pointe Scientific, Inc.,
- K070757 — MICROPROTEIN REAGENT SET
- K062118 — POINTE 360
- K070251 — CARBON DIOXIDE LIQUID STABLE REAGENT
- K070207 — MULTI-ANALYTE CHEMISTRY CALIBRATOR
- K070504 — AMMONIA/ALCOHOL CONTROL SET
- K061377 — APOLIPOPROTEIN A1 AND APOLIPOPROTEIN B REAGENTS AND CALIBRATORS
- K051646 — ISE DILUENT, 1N KCL, INTERNAL REFERENCE AND ISE STANDARDS LOW AND HIGH
- K040391 — TOTAL BILIRUBIN REAGENT SET
- K031539 — HEMOGLOBIN A1C REAGENT SET
- K023860 — MICROALBUMIN REAGENT SET AND CALIBRATORS
- K024006 — G6PDH, GLUCOSE-6-PHOSHATE DEHYDROGENASE
- K023396 — AMYLASE EPS-G7 (LIQUID) REAGENT SET, (HITACHI ANALYZERS)
- K002199 — MODIFICATION TO LIQUID GLUCOSE (HEXOKINASE) REAGENT SET
- K002651 — C-REACTIVE PROTEIN (HIGH SENSITIVITY) REAGENT SET
- K993590 — FRUCTOSAMINE REAGENT SET, CALIBRATOR, AND CONTROL SET
- K992002 — AUTOHDL CHOLESTEROL REAGENT SET
- K981978 — AUTOLDL CHOLESTEROL REAGENT SET AND AUTOLDL CHOLESTEROL CALIBRATOR
- K973588 — LIQUID ALKALINE PHOSHATASE REAGENT SET
- K973157 — LIQUID GGT (GAMMA GLUTAMYL TRANSFERASE) REAGENT SET
- K973589 — LIQUID LDH-L REAGENT SET
- K972725 — ALCOHOL REAGENT SET
- K971754 — LIQUID GLUCOSE (HEXOKINASE) REAGENT SET
- K972671 — BUN (LIQUID) REAGENT SET
- K970933 — AUTO HDL CHOLESTEROL CALIBRATOR
- K970781 — LIQUID GLUCOSE (OXIDASE) REAGENT SET
- K970560 — URIC ACID (LIQUID) REAGENT SET
- K961588 — TOTAL IRON (NITRO-PAPS) REAGENT SET
- K961431 — LACTATE DEHYDROGENASE REAGENT SET
- K940735 — LIQUID AMYLASE (CNPG3) REAGENT SET
- K941287 — LIQUID ALT(SGPT) REAGENT SET
- K941132 — LIQUID AST (SGOT)REAGENT SET
- K935463 — CREATINE KINASE-MB (CK-MB) REAGENT SET
- K930475 — LIQUID AMYLASE REAGENT SET
- K930660 — CREATINE KINASE (CK) REAGENT SET
- K920449 — POINTE 750 GLYCOMETER
- K921625 — CALCIUM-ARSENAZO III REAGENT SET
- K914873 — DIAZO COLORIMETRY, BILIRUBIN
- K910158 — AMYLASE
- K896812 — CARBON DIOXIDE REAGENT
- K896590 — CARBON DIOXIDE REAGENT
- K891117 — HDL CHOLESTEROL REAGENT
- K874131 — CRESOLPHTHALEIN COMPLEXONE, CALCIUM
- K864464 — PSI AMYLASE REAGENT
- K864882 — FERROZINE (COLORIMETRIC) IRON BINDING CAPACITY
- K863832 — NAPHTHYL PHOSPHATE, ACID PHOSPHATASE
- K862033 — TRIGLYCERIDES
- K860572 — GLYCOHEMOGLOBIN, IN-VITRO DIAGNOSTIC REAGENT SET
- K860257 — DIRECT BILIRUBIN
- K853592 — MAGNESIUM
- K852169 — CHLORIDE REAGENT
- K851432 — HEMOGLOBIN
- K832889 — AMYLASE
- K832871 — LIPASE HYDROLYSIS/GLYCEROL KINASE
- K832872 — HEXOKINASE, GLUCOSE
- K832870 — DIAZO COLORIMETRY, BILLIRUBIN
- K830556 — CREATININE
- K822468 — PSI TOTAL PROTEIN REAGENT
- K822469 — PSI CALCIUM REAGENT
- K822470 — PSI INORGANIC PHOSPHORUS
- K822471 — PSI ALBUMIN REAGENT
- K813495 — ALT (SGPT)
- K813496 — LDH-L
- K813405 — AST(SGOT) IN VITRO DIAG. REAGENT SET
- K813406 — CPK(CK) IN VITRO DIAG. REAGENT SET
- K812794 — LIPASE
- K812699 — AMYLASE
- K812574 — HDL CHOLESTEROL REAGENT
- K812430 — URIC ACID REAGENT SET
- K812452 — ALKALINE PHOSPHATASE
- K812341 — UREA NITROGEN (BUN)
- K812296 — GAMMA GLUTAMY TRANSPEPTIDASE
- K810673 — ENZYMATIC CHOLESTEROL
- K810674 — GLUCOSE OXIDASE
- K810680 — ENZYMATIC TRIGLYCERIDE
Data sourced from openFDA. This site is unofficial and independent of the FDA.