Pointe Scientific, Inc., is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Pointe Scientific, Inc., - FDA 510(k) Cleared Devices
74
Total
74
Cleared
0
Denied
Pointe Scientific, Inc., has 74 FDA 510(k) cleared chemistry devices. Based in Mchenry, US.
Historical record: 74 cleared submissions from 1981 to 2007.
Browse the complete list of FDA 510(k) cleared chemistry devices from this manufacturer. Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - Pointe Scientific, Inc.,
74 devices
Cleared
Dec 04, 2007
MICROPROTEIN REAGENT SET
Chemistry
259d
Cleared
Jul 13, 2007
POINTE 360
Chemistry
353d
Cleared
Apr 30, 2007
CARBON DIOXIDE LIQUID STABLE REAGENT
Chemistry
94d
Cleared
Apr 13, 2007
MULTI-ANALYTE CHEMISTRY CALIBRATOR
Chemistry
81d
Cleared
Apr 11, 2007
AMMONIA/ALCOHOL CONTROL SET
Chemistry
49d
Cleared
Mar 28, 2007
APOLIPOPROTEIN A1 AND APOLIPOPROTEIN B REAGENTS AND CALIBRATORS
Chemistry
315d
Cleared
Oct 07, 2005
ISE DILUENT, 1N KCL, INTERNAL REFERENCE AND ISE STANDARDS LOW AND HIGH
Chemistry
108d
Cleared
Jun 02, 2004
TOTAL BILIRUBIN REAGENT SET
Chemistry
106d
Cleared
Aug 06, 2003
HEMOGLOBIN A1C REAGENT SET
Chemistry
82d
Cleared
Apr 28, 2003
MICROALBUMIN REAGENT SET AND CALIBRATORS
Chemistry
159d
Cleared
Mar 31, 2003
G6PDH, GLUCOSE-6-PHOSHATE DEHYDROGENASE
Chemistry
117d
Cleared
Dec 23, 2002
AMYLASE EPS-G7 (LIQUID) REAGENT SET, (HITACHI ANALYZERS)
Chemistry
75d
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