FDA 510(k) Applications Submitted by PRISCILLA A HAMILL

FDA 510(k) Number Submission Date Device Name Applicant
K990460 02/12/1999 CALIBRATOR FOR AUTOMATED SYSTEMS (C.F.A.S.) ROCHE DIAGNOSTICS CORP.
K990594 02/24/1999 INTEGRA REAGENT CASSETTE FOR APOLIPOPROTEIN A-1 ROCHE DIAGNOSTICS CORP.
K990595 02/24/1999 INTEGRA REAGENT CASSETTE FOR APOLIPOPROTEIN B ROCHE DIAGNOSTICS CORP.
K990992 03/24/1999 INTEGRA REAGENT CASSETTE FOR HEMOGLOBIN ALC ROCHE DIAGNOSTICS CORP.
K981401 04/17/1998 BOEHRINGER MANNHEIM PRECINORM PRECIPATH PROTEIN CONTROLS BOEHRINGER MANNHEIM CORP.
K001468 05/10/2000 ELECSYS CA 15-3 TEST SYSTEM ROCHE DIAGNOSTICS CORP.
K002148 07/17/2000 ELECSYS HCG TEST SYSTEM ROCHE DIAGNOSTICS CORP.
K992680 08/10/1999 ELECSYS PARATHYROID HORMONE TEST SYSTEM ROCHE DIAGNOSTICS CORP.
K982948 08/21/1998 ELECSYS PSA, MODEL # ELECSYS 1010 BOEHRINGER MANNHEIM CORP.
K982949 08/21/1998 ELECSYS PSA, MODEL 2010 BOEHRINGER MANNHEIM CORP.
K992981 09/03/1999 ELECSYS ESTRADIOL CALSET II ROCHE DIAGNOSTICS CORP.
K983166 09/10/1998 ELECSYS CALCHECK MYOGLOBIN BOEHRINGER MANNHEIM CORP.
K983176 09/10/1998 ELECSYS MYOGLOBIN STAT ASSAY BOEHRINGER MANNHEIM CORP.
K983185 09/11/1998 BOEHRINGER MANNHEIM TINA-QUANT IGE TEST BOEHRINGER MANNHEIM CORP.
K983469 10/01/1998 PRECISET SERUM PROTEINS CALIBRATOR BOEHRINGER MANNHEIM CORP.
K983492 10/05/1998 BOEHRINGER MANNHEIM ELECSYS PRESICONTROL CARDIAC BOEHRINGER MANNHEIM CORP.
K993360 10/06/1999 PRECINORM UNIVERSAL PLUS AND PRECIPATH UNIVERSAL PLUS CONTROL SERA ROCHE DIAGNOSTICS CORP.
K003261 10/18/2000 CREATININE PLUS ROCHE DIAGNOSTICS CORP.
K993642 10/28/1999 ELECSYS PARATHYROID HORMONE CALCHECK ROCHE DIAGNOSTICS CORP.
K993706 11/02/1999 ELECSYS SERUM B-CROSSLAPS/SERUM IMMUNOASSAY ROCHE DIAGNOSTICS CORP.
K984105 11/17/1998 ELECSYS TROPONIN T STAT TEST BOEHRINGER MANNHEIM CORP.
K984326 12/03/1998 ELECYS IGE ASSAY BOEHRINGER MANNHEIM CORP.
K984372 12/07/1998 ELECSYS CALCHECK TROPONIN T BOEHRINGER MANNHEIM CORP.
K984419 12/10/1998 ELECSYS IGE CALCHECK BOEHRINGER MANNHEIM CORP.
K984425 12/11/1998 MODIFICATION OF PRECISET SERUM PROTEINS CALIBRATOR BOEHRINGER MANNHEIM CORP.


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