FDA 510(k) Applications Submitted by POINTE SCIENTIFIC, INC.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K070207 |
01/22/2007 |
MULTI-ANALYTE CHEMISTRY CALIBRATOR |
POINTE SCIENTIFIC, INC. |
| K040391 |
02/17/2004 |
TOTAL BILIRUBIN REAGENT SET |
POINTE SCIENTIFIC, INC. |
| K070504 |
02/21/2007 |
AMMONIA/ALCOHOL CONTROL SET |
POINTE SCIENTIFIC, INC. |
| K070757 |
03/20/2007 |
MICROPROTEIN REAGENT SET |
POINTE SCIENTIFIC, INC. |
| K002199 |
07/20/2000 |
MODIFICATION TO LIQUID GLUCOSE (HEXOKINASE) REAGENT SET |
POINTE SCIENTIFIC, INC. |
| K062118 |
07/25/2006 |
POINTE 360 |
POINTE SCIENTIFIC, INC. |
| K002651 |
08/25/2000 |
C-REACTIVE PROTEIN (HIGH SENSITIVITY) REAGENT SET |
POINTE SCIENTIFIC, INC. |
| K023396 |
10/09/2002 |
AMYLASE EPS-G7 (LIQUID) REAGENT SET, (HITACHI ANALYZERS) |
POINTE SCIENTIFIC, INC. |
| K023860 |
11/20/2002 |
MICROALBUMIN REAGENT SET AND CALIBRATORS |
POINTE SCIENTIFIC, INC. |
| K024006 |
12/04/2002 |
G6PDH, GLUCOSE-6-PHOSHATE DEHYDROGENASE |
POINTE SCIENTIFIC, INC. |
| K061377 |
05/17/2006 |
APOLIPOPROTEIN A1 AND APOLIPOPROTEIN B REAGENTS AND CALIBRATORS |
POINTE SCIENTIFIC, INC. |
| K970781 |
03/04/1997 |
LIQUID GLUCOSE (OXIDASE) REAGENT SET |
POINTE SCIENTIFIC, INC. |
| K961431 |
04/15/1996 |
LACTATE DEHYDROGENASE REAGENT SET |
POINTE SCIENTIFIC, INC. |
| K961588 |
04/24/1996 |
TOTAL IRON (NITRO-PAPS) REAGENT SET |
POINTE SCIENTIFIC, INC. |
| K971754 |
05/12/1997 |
LIQUID GLUCOSE (HEXOKINASE) REAGENT SET |
POINTE SCIENTIFIC, INC. |
| K031539 |
05/16/2003 |
HEMOGLOBIN A1C REAGENT SET |
POINTE SCIENTIFIC, INC. |
| K992002 |
06/15/1999 |
AUTOHDL CHOLESTEROL REAGENT SET |
POINTE SCIENTIFIC, INC. |
| K051646 |
06/21/2005 |
ISE DILUENT, 1N KCL, INTERNAL REFERENCE AND ISE STANDARDS LOW AND HIGH |
POINTE SCIENTIFIC, INC. |
| K972671 |
07/16/1997 |
BUN (LIQUID) REAGENT SET |
POINTE SCIENTIFIC, INC. |
| K972725 |
07/21/1997 |
ALCOHOL REAGENT SET |
POINTE SCIENTIFIC, INC. |
| K973157 |
08/22/1997 |
LIQUID GGT (GAMMA GLUTAMYL TRANSFERASE) REAGENT SET |
POINTE SCIENTIFIC, INC. |
| K973588 |
09/22/1997 |
LIQUID ALKALINE PHOSHATASE REAGENT SET |
POINTE SCIENTIFIC, INC. |
| K973589 |
09/22/1997 |
LIQUID LDH-L REAGENT SET |
POINTE SCIENTIFIC, INC. |
| K993590 |
10/22/1999 |
FRUCTOSAMINE REAGENT SET, CALIBRATOR, AND CONTROL SET |
POINTE SCIENTIFIC, INC. |
| K970560 |
02/13/1997 |
URIC ACID (LIQUID) REAGENT SET |
POINTE SCIENTIFIC, INC. |
| K070251 |
01/26/2007 |
CARBON DIOXIDE LIQUID STABLE REAGENT |
POINTE SCIENTIFIC, INC. |
| K970933 |
03/13/1997 |
AUTO HDL CHOLESTEROL CALIBRATOR |
POINTE SCIENTIFIC, INC. |
| K981978 |
06/05/1998 |
AUTOLDL CHOLESTEROL REAGENT SET AND AUTOLDL CHOLESTEROL CALIBRATOR |
POINTE SCIENTIFIC, INC. |
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