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Pointe Scientific, Inc.,

74 FDA 510(k) clearances · Manufacturer

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RecordFirmDate
MICROPROTEIN REAGENT SET (K070757)Pointe Scientific, Inc.,2007-12-04
POINTE 360 (K062118)Pointe Scientific, Inc.,2007-07-13
CARBON DIOXIDE LIQUID STABLE REAGENT (K070251)Pointe Scientific, Inc.,2007-04-30
MULTI-ANALYTE CHEMISTRY CALIBRATOR (K070207)Pointe Scientific, Inc.,2007-04-13
AMMONIA/ALCOHOL CONTROL SET (K070504)Pointe Scientific, Inc.,2007-04-11
APOLIPOPROTEIN A1 AND APOLIPOPROTEIN B REAGENTS AND CALIBRATORS (K061377)Pointe Scientific, Inc.,2007-03-28
ISE DILUENT, 1N KCL, INTERNAL REFERENCE AND ISE STANDARDS LOW AND HIGH (K051646)Pointe Scientific, Inc.,2005-10-07
TOTAL BILIRUBIN REAGENT SET (K040391)Pointe Scientific, Inc.,2004-06-02
HEMOGLOBIN A1C REAGENT SET (K031539)Pointe Scientific, Inc.,2003-08-06
MICROALBUMIN REAGENT SET AND CALIBRATORS (K023860)Pointe Scientific, Inc.,2003-04-28
G6PDH, GLUCOSE-6-PHOSHATE DEHYDROGENASE (K024006)Pointe Scientific, Inc.,2003-03-31
AMYLASE EPS-G7 (LIQUID) REAGENT SET, (HITACHI ANALYZERS) (K023396)Pointe Scientific, Inc.,2002-12-23
MODIFICATION TO LIQUID GLUCOSE (HEXOKINASE) REAGENT SET (K002199)Pointe Scientific, Inc.,2000-11-20
C-REACTIVE PROTEIN (HIGH SENSITIVITY) REAGENT SET (K002651)Pointe Scientific, Inc.,2000-10-13
FRUCTOSAMINE REAGENT SET, CALIBRATOR, AND CONTROL SET (K993590)Pointe Scientific, Inc.,1999-12-21
AUTOHDL CHOLESTEROL REAGENT SET (K992002)Pointe Scientific, Inc.,1999-08-05
AUTOLDL CHOLESTEROL REAGENT SET AND AUTOLDL CHOLESTEROL CALIBRATOR (K981978)Pointe Scientific, Inc.,1998-07-22
LIQUID ALKALINE PHOSHATASE REAGENT SET (K973588)Pointe Scientific, Inc.,1997-10-22
LIQUID GGT (GAMMA GLUTAMYL TRANSFERASE) REAGENT SET (K973157)Pointe Scientific, Inc.,1997-10-10
LIQUID LDH-L REAGENT SET (K973589)Pointe Scientific, Inc.,1997-10-08
ALCOHOL REAGENT SET (K972725)Pointe Scientific, Inc.,1997-09-25
LIQUID GLUCOSE (HEXOKINASE) REAGENT SET (K971754)Pointe Scientific, Inc.,1997-07-22
BUN (LIQUID) REAGENT SET (K972671)Pointe Scientific, Inc.,1997-07-20
AUTO HDL CHOLESTEROL CALIBRATOR (K970933)Pointe Scientific, Inc.,1997-05-23
LIQUID GLUCOSE (OXIDASE) REAGENT SET (K970781)Pointe Scientific, Inc.,1997-04-21
URIC ACID (LIQUID) REAGENT SET (K970560)Pointe Scientific, Inc.,1997-03-11
TOTAL IRON (NITRO-PAPS) REAGENT SET (K961588)Pointe Scientific, Inc.,1996-11-18
LACTATE DEHYDROGENASE REAGENT SET (K961431)Pointe Scientific, Inc.,1996-06-03
LIQUID AMYLASE (CNPG3) REAGENT SET (K940735)Pointe Scientific, Inc.,1994-08-01
LIQUID ALT(SGPT) REAGENT SET (K941287)Pointe Scientific, Inc.,1994-05-03
LIQUID AST (SGOT)REAGENT SET (K941132)Pointe Scientific, Inc.,1994-05-02
CREATINE KINASE-MB (CK-MB) REAGENT SET (K935463)Pointe Scientific, Inc.,1994-01-11
LIQUID AMYLASE REAGENT SET (K930475)Pointe Scientific, Inc.,1993-07-19
CREATINE KINASE (CK) REAGENT SET (K930660)Pointe Scientific, Inc.,1993-03-29
POINTE 750 GLYCOMETER (K920449)Pointe Scientific, Inc.,1992-07-28
CALCIUM-ARSENAZO III REAGENT SET (K921625)Pointe Scientific, Inc.,1992-05-13
DIAZO COLORIMETRY, BILIRUBIN (K914873)Pointe Scientific, Inc.,1991-12-04
AMYLASE (K910158)Pointe Scientific, Inc.,1991-04-30
CARBON DIOXIDE REAGENT (K896812)Pointe Scientific, Inc.,1990-02-23
CARBON DIOXIDE REAGENT (K896590)Pointe Scientific, Inc.,1990-02-01
HDL CHOLESTEROL REAGENT (K891117)Pointe Scientific, Inc.,1989-04-10
CRESOLPHTHALEIN COMPLEXONE, CALCIUM (K874131)Pointe Scientific, Inc.,1987-12-04
FERROZINE (COLORIMETRIC) IRON BINDING CAPACITY (K864882)Pointe Scientific, Inc.,1987-01-21
PSI AMYLASE REAGENT (K864464)Pointe Scientific, Inc.,1987-01-21
NAPHTHYL PHOSPHATE, ACID PHOSPHATASE (K863832)Pointe Scientific, Inc.,1986-12-16
TRIGLYCERIDES (K862033)Pointe Scientific, Inc.,1986-07-22
GLYCOHEMOGLOBIN, IN-VITRO DIAGNOSTIC REAGENT SET (K860572)Pointe Scientific, Inc.,1986-05-16
DIRECT BILIRUBIN (K860257)Pointe Scientific, Inc.,1986-02-21
MAGNESIUM (K853592)Pointe Scientific, Inc.,1985-09-16
CHLORIDE REAGENT (K852169)Pointe Scientific, Inc.,1985-08-21
HEMOGLOBIN (K851432)Pointe Scientific, Inc.,1985-07-12
AMYLASE (K832889)Pointe Scientific, Inc.,1983-11-25
HEXOKINASE, GLUCOSE (K832872)Pointe Scientific, Inc.,1983-10-14
LIPASE HYDROLYSIS/GLYCEROL KINASE (K832871)Pointe Scientific, Inc.,1983-10-14
DIAZO COLORIMETRY, BILLIRUBIN (K832870)Pointe Scientific, Inc.,1983-09-26
CREATININE (K830556)Pointe Scientific, Inc.,1983-03-24
PSI CALCIUM REAGENT (K822469)Pointe Scientific, Inc.,1982-09-14
PSI ALBUMIN REAGENT (K822471)Pointe Scientific, Inc.,1982-09-14
PSI INORGANIC PHOSPHORUS (K822470)Pointe Scientific, Inc.,1982-09-14
PSI TOTAL PROTEIN REAGENT (K822468)Pointe Scientific, Inc.,1982-09-14
ALT (SGPT) (K813495)Pointe Scientific, Inc.,1981-12-31
LDH-L (K813496)Pointe Scientific, Inc.,1981-12-31
CPK(CK) IN VITRO DIAG. REAGENT SET (K813406)Pointe Scientific, Inc.,1981-12-22
AST(SGOT) IN VITRO DIAG. REAGENT SET (K813405)Pointe Scientific, Inc.,1981-12-22
LIPASE (K812794)Pointe Scientific, Inc.,1981-10-20
AMYLASE (K812699)Pointe Scientific, Inc.,1981-10-06
HDL CHOLESTEROL REAGENT (K812574)Pointe Scientific, Inc.,1981-09-24
ALKALINE PHOSPHATASE (K812452)Pointe Scientific, Inc.,1981-09-09
URIC ACID REAGENT SET (K812430)Pointe Scientific, Inc.,1981-09-09
UREA NITROGEN (BUN) (K812341)Pointe Scientific, Inc.,1981-09-01
GAMMA GLUTAMY TRANSPEPTIDASE (K812296)Pointe Scientific, Inc.,1981-08-31
ENZYMATIC CHOLESTEROL (K810673)Pointe Scientific, Inc.,1981-03-31
ENZYMATIC TRIGLYCERIDE (K810680)Pointe Scientific, Inc.,1981-03-31
GLUCOSE OXIDASE (K810674)Pointe Scientific, Inc.,1981-03-31

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Every clearance here is in the API, with alerts when new ones post.