FDA 510(k) Applications Submitted by WILLIAM L BOTELER JR.
FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
K990765 |
03/08/1999 |
FLEXFINDER GUIDE WIRE(REGULAR SHAFT/STIFF SHAFT) MARKED INK BANDS, FLEXFINDER GUIDE WIRE (REGULAR SHAFT/STIFF SHAFT) NO |
FLEXMEDICS |
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. |
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. |
K180679 |
03/15/2018 |
CitriCon Liquid and Powder (Acid Concentrate acidified with Citric Acid), AcetiCon Liquid and Powder (Acid Concentrate acidified with Acetic Acid or Na Di Acetate), BicarboCon Liquid and Powder (Bicarb Concentrate), RenaCon Liquid and Powder (Acetate Conc |
Global Scientific Technologies, LLC |
K982762 |
08/06/1998 |
SEARE BIOMEDICAL PECTORALIS IMPLANT |
SEARE BIOMEDICAL CORP. |
K982763 |
08/06/1998 |
SEARE BIOMEDICAL MALAR IMPLANTS |
SEARE BIOMEDICAL CORP. |
K983630 |
10/15/1998 |
SEARE BIOMEDICAL SILICONE RODS |
SEARE BIOMEDICAL CORP. |
K963318 |
08/23/1996 |
LEGIONELLA IGG/IGM ELISA TEST SYSTEM |
ARMKEL, LLC. |
K961764 |
05/07/1996 |
PR-3 ELISA TEST SYSTEM |
IMMUNO PROBE, INC. |
K981750 |
05/18/1998 |
WIELISA ANTI-GBM, ANCA SCREENING KIT TEST SYSTEM |
WIESLAB AB |
K051455 |
06/02/2005 |
WIESLAB CAP MPO-ANCA |
EURODIAGNOSTICA |
K051458 |
06/02/2005 |
WIESLAB CAP PR-3 ANCA |
EURODIAGNOSTICA |
K052133 |
08/05/2005 |
IMMUNOSCAN RA ANTI-CCP TEST SYSTEM |
EURODIAGNOSTICA |
K965129 |
12/23/1996 |
BORRELIA BURGDORFERI IGM ELISA TEST SYSTEM |
WAMPOLE LABORATORIES |
K965131 |
12/23/1996 |
BORRELIA BURGDORFERI IGG/IGM ELISA TEST SYSTEM |
WAMPOLE LABORATORIES |
K980596 |
02/17/1998 |
VCA IGM ELISA TEST SYSTEM |
CLARK LABORATORIES, INC. |
K980598 |
02/17/1998 |
EBNA-1 IGM ELISA TEST SYSTEM |
CLARK LABORATORIES, INC. |
K981748 |
05/18/1998 |
WIELISA ANCA SCREENING KIT TEST SYSTEM |
WIESLAB AB |
K963645 |
09/12/1996 |
HERPES GROUP IGG ELISA TEST SYSTEM |
ARMKEL, LLC. |
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