FDA 510(k) Applications Submitted by GABRIEL J MURACA, JR.

FDA 510(k) Number Submission Date Device Name Applicant
K993711 11/03/1999 ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM (INVITRO DIAGNOSTIC SYSTEM WITH 5 ADDITIONAL ASSAYS) BAYER CORP.
K031001 03/31/2003 ACMI VISTA CTR BIPOLAR LOOP ELECTRODE ACMI CORPORATION
K061103 04/20/2006 HAEMONETICS 40U RBC FILTER BAG HAEMONETICS CORP.
K991576 05/06/1999 ADDITIONAL ASSAYS FOR THE BAYER ADVIA 1650 CHEMISTRY SYSTEM BAYER CORP.
K971989 05/29/1997 TOXOPLASMA IGM ASSAY FOR THE BAYER IMMUNO1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM) BAYER CORP.
K971998 05/30/1997 ADVIA 120 HEMATOLOGY SYSTEM, IN VITRO DIAGNOSTIC SYSTEM BAYER CORP.
K031758 06/06/2003 ACMI M4 TELESCOPES ACMI CORPORATION
K992136 06/24/1999 BAYER ADVIA INTEGRATED MODULAR SYSTEM (IMS) BAYER CORP.
K972462 07/01/1997 AFP ASSAY FOR THE BAYER IMMUNO 1 SYSTEM BAYER CORP.
K992228 07/02/1999 BAYER IMMUNO 1 HER-2/NEU ASSAY BAYER CORP.
K972580 07/10/1997 DEOXYPYRIDINOLINE ASSAY FOR THE BAYER IMMUNO 1 SYSTEM BAYER CORP.
K992662 08/09/1999 8 ADDITIONAL ASSAYS FOR THE BAYER ADVIA 1650 CHEMISTRY SYSTEM BAYER CORP.
K982802 08/10/1998 BAYER ADVIA 60 HEMATOLOGY SYSTEM (IN VITRO DIAGNOSTIC SYSTEM) BAYER CORP.
K954332 09/18/1995 RBCFOLATE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM BAYER CORP.
K062801 09/19/2006 SMARTSUCTION SOLO DEVICE HAEMONETICS CORP.
K973616 09/23/1997 TROPONIN I ASSAY FOR THE BAYER IMMUNO 1 SYSTEM BAYER CORP.
K052626 09/23/2005 SMARTSUCTION HARMONY DEVICE HAEMONETICS CORP.
K954594 10/03/1995 RETICULOCYTE METHOD, RBC INDICES BAYER CORP.
K954607 10/04/1995 RETICULOCYTE METHOD BAYER CORP.
K053000 10/25/2005 HAEMONETICS CARDIOVASCULAR PERIOPERATIVE AUTOTRANSFUSION SYSTEM (CARDIOPAT) HAEMONETICS CORP.
K043127 11/12/2004 HAEMONETICS CARDIOVASCULAR PERIOPERATIVE AUTOTRANSFUSION SYSTEM HAEMONETICS CORP.
K993867 11/15/1999 BAYER ADVIA IMS SYSTEM BAYER CORP.
K983345 09/23/1998 BAYER IMMUNO 1 SYSTEM, UPGRADED FOR A LABORATORY BAYER CORP.
K993353 10/05/1999 TROPONIN I ASSAY FOR THE BAYER IMMUNO 1 SYSTEM ( IN VITRO DIAGNOSTIC SYSTEM) BAYER CORP.
K991817 05/27/1999 ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM BAYER CORP.
K001764 06/12/2000 HOTLINE 2 FLUID WARMER SIMS LEVEL 1, INC.
K982328 07/02/1998 BAYER ADVIA IMS SYSTEM (IN VITRO DIAGNOSTIC SYSTEM) BAYER CORP.
K974721 12/18/1997 UNCONJUGATED ESTRIOL ASSAY FOR THE BAYER IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM) BAYER CORP.
K955760 12/20/1995 TOXOPLASMA IGG IN-VITRO DIAGNOSTIC SYSTEM BAYER CORP.
K991907 06/07/1999 ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM BAYER CORP.
K980521 01/28/1998 DIGOXIN ASSAY FOR THE TECHNICON RA / OPERA SYSTEMS BAYER CORP.
K980376 01/30/1998 THE COMPLEXED PSA ASSAY FOR THE BAYER IMMUNO 1 SYSTEM BAYER CORP.
K990346 02/04/1999 BAYER ADVIA 1650 CHEMISTRY SYSTEM BAYER CORP.
K951359 03/27/1995 RUBELLA IGG ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM IN-VITRO DIAGNOSTIC DEVICE BAYER CORP.
K121005 04/03/2012 ADIPREP ADIPOSE TRANSFER SYSTEM HARVEST TECHNOLOGIES, CORP.
K961351 04/05/1996 HCG ER METHOD FOR THE TECHNICON IMMUNO 1 SYSTEM IN-VITRO DIAGNOSTIC CLINICAL METHOD BAYER CORP.
K981312 04/10/1998 3RD GENERATION TSH ASSAY FOR THE BAYER IMMUNO 1 SYSTEM BAYER CORP.
K961412 04/12/1996 CK-MB METHOD FOR THE TECHNICON IMMUNO 1 SYSTEM IN-VITRO BAYER CORP.
K971716 05/09/1997 PROCAINAMIDE ASSAY FOR THE BAYER IMMUNO 1 SYSTEM BAYER CORP.
K971713 05/09/1997 N-ACETYLPROCAINAMIDE ASSAY FOR THE BAYER IMMUNO 1 SYSTEM BAYER CORP.
K962125 06/03/1996 TECHNICON IMMUNO 1 SYSTEM BAYER CORP.
K962355 06/18/1996 FREE TRIIODOTHYRONINE(FT3) ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN-VITRO DIAGNOSTIC SYSTEM) BAYER CORP.
K962344 06/18/1996 MYOGLOBIN ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN-VITRO DIAGNOSTIC SYSTEM) BAYER CORP.
K011907 06/18/2001 SNUGGLE WARM 4000 CONVECTIVE WARMING SYSTEM SIMS LEVEL 1, INC.
K982714 08/04/1998 BAYER IMMUNO 1 SYSTEM FERRITIN ASSAY BAYER CORP.
K963080 08/08/1996 TESTOSTERONEE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN-VITRO DIAGNOSTIC SYSTEM) BAYER CORP.
K964068 10/10/1996 CARBAMAZEPINE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM BAYER CORP.
K964098 10/11/1996 CPA 125 II ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM BAYER CORP.
K964116 10/15/1996 QUINIDINE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM) BAYER CORP.
K983715 10/21/1998 THE IMMUNO 1 CA 125 II ASSAY FOR THE BAYER IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM) BAYER CORP.
K964442 11/06/1996 VALPROIC ACID ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM BAYER CORP.
K955087 11/07/1995 HEMOGLOBIN ALC (HBA1C) & TOTAL ASSAYS FOR THE TECHNICON RA/OPERA SYSTEMS IN-VITRO DIAGNOSTIC SYSTEMS BAYER CORP.
K964587 11/15/1996 VANCOMYCIN ASSAY OR THE TECHNICON IMMUNO 1 SYSTEM BAYER CORP.
K964703 11/22/1996 THE CA 15-3 ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM) BAYER CORP.
K964791 11/29/1996 B2 MICROGLOBULIN ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM) BAYER CORP.
K992399 07/19/1999 ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM BAYER CORP.


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