Em Diagnostic Systems Inc

FDA Filings

This page includes the latest FDA filings for Em Diagnostic Systems Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

FDA Filings

Device
Company
DeviceDate
EM DIAGNOSTIC SYSTEMS, INC.
ASPARTATE AMINOTRANSFERASE (AST) TEST1994-01-27
EM DIAGNOSTIC SYSTEMS, INC.
ALANINE AMINOTRANSFERASE (ALT) TEST1994-01-13
EM DIAGNOSTIC SYSTEMS, INC.
EMDS ALBUMIN (ALB) TEST1993-12-17
EM DIAGNOSTIC SYSTEMS, INC.
EMDS PHOSPHOROUS (PHOS) TEST1993-12-17
EM DIAGNOSTIC SYSTEMS, INC.
GAMMA-GLUTAMYL TRANSFERASE (GGT) TEST1993-12-16
EM DIAGNOSTIC SYSTEMS, INC.
IRON TEST1993-12-16
EM DIAGNOSTIC SYSTEMS, INC.
LACTATE DEHYDROGENASE (LD)1993-12-16
EM DIAGNOSTIC SYSTEMS, INC.
TOTAL PROTEIN TEST (TPRO)1993-12-16
EM DIAGNOSTIC SYSTEMS, INC.
CHOLESTEROL (CHOL) TEST ITEM NO. 654101993-12-16
EM DIAGNOSTIC SYSTEMS, INC.
EMDS MAGNESIUM (MG) TEST1993-12-09
EM DIAGNOSTIC SYSTEMS, INC.
EMDS ALKANINE PHOSPHATASE (ALP) TEST1993-12-09
EM DIAGNOSTIC SYSTEMS, INC.
URIC ACID TEST ITEM NUMBER 654221993-09-27
EM DIAGNOSTIC SYSTEMS, INC.
CALCIUM TEST ITEM NUMBER 654091993-09-27
EM DIAGNOSTIC SYSTEMS, INC.
SYSTEMATE DIRECT BILIRUBIN CAT. NO. 654061993-09-21
EM DIAGNOSTIC SYSTEMS, INC.
UREA NITROGEN TEST ITEM NUMBER 654081993-09-08
EM DIAGNOSTIC SYSTEMS, INC.
TRIGLYCERIDES1993-08-25
EM DIAGNOSTIC SYSTEMS, INC.
SILYL AMYL1993-08-19
EM DIAGNOSTIC SYSTEMS, INC.
ETHYLIDENE AMYL1993-08-19
EM DIAGNOSTIC SYSTEMS, INC.
BICARBONATE1993-08-03
EM DIAGNOSTIC SYSTEMS, INC.
CREATINE KINASE TEST1993-07-27
EM DIAGNOSTIC SYSTEMS, INC.
TOTAL BILIRUBIN1993-07-27
EM DIAGNOSTIC SYSTEMS, INC.
GLUCOSE-HK TEST1993-07-22
EM DIAGNOSTIC SYSTEMS, INC.
SYSTEMATE CREATININE TEST ITEM NUMBER 654131993-07-09
EM DIAGNOSTIC SYSTEMS, INC.
IRON TEST #'S 42376/93,42324/R1A,42324/R1B,42324/R1993-04-21
EM DIAGNOSTIC SYSTEMS, INC.
SYSTEMATE PLUS CALIBRATOR1993-02-23
EM DIAGNOSTIC SYSTEMS, INC.
ABBOTT QUICKSTART LD-1, MODIFICATION1993-02-05
EM DIAGNOSTIC SYSTEMS, INC.
LACTATE DEHYDROGENASE (LD) TEST ITEM #654181993-02-05
EM DIAGNOSTIC SYSTEMS, INC.
CHOLESTEROL TEST ITEM# 42374/93, 42322/R11993-01-28
EM DIAGNOSTIC SYSTEMS, INC.
TRIGLYCERIDES1993-01-26
EM DIAGNOSTIC SYSTEMS, INC.
UREA NITROGEN TEST1993-01-04
EM DIAGNOSTIC SYSTEMS, INC.
ALBUMIN TEST1992-12-28
EM DIAGNOSTIC SYSTEMS, INC.
BICARBONATE1992-12-03
EM DIAGNOSTIC SYSTEMS, INC.
EMDS GLUCOSE (GLU-HK) TEST, ITEM 654151992-11-25
EM DIAGNOSTIC SYSTEMS, INC.
EMDS ALKALINE PHOSPHATASE (ALP) TEST1992-11-09
EM DIAGNOSTIC SYSTEMS, INC.
SYSTEMATE PLUS TRIGLYCERIDE-GLYCEROL BLANKED TEST1992-11-06
EM DIAGNOSTIC SYSTEMS, INC.
CHOLESTEROL TEST1992-10-26
EM DIAGNOSTIC SYSTEMS, INC.
CREATININE-IP TEST, # 42375/93, 42323/R1, 42323/R21992-10-15
EM DIAGNOSTIC SYSTEMS, INC.
TWO PART INORGANIC PHOSPHORUS TEST1992-10-14
EM DIAGNOSTIC SYSTEMS, INC.
CREATINE KINASE (CK) TEST ITEM #654111992-10-13
EM DIAGNOSTIC SYSTEMS, INC.
EMDS ALANINE AMINOTRANSFER TEST(ALT) TECH RA 10001992-09-28
EM DIAGNOSTIC SYSTEMS, INC.
GAMMA GULTAMYL TRANSFERASE TEST1992-09-28
EM DIAGNOSTIC SYSTEMS, INC.
SYSTEMATE URICACID TEST, TECHNICON RA 10001992-09-22
EM DIAGNOSTIC SYSTEMS, INC.
SYSTEMATE PHOSPHORUS TEST TECHNICON RA 10001992-09-22
EM DIAGNOSTIC SYSTEMS, INC.
AMYLASE TEST1992-09-09
EM DIAGNOSTIC SYSTEMS, INC.
SYSTEMATE TOTAL PROTEIN TEST, TECHNICON RA 10001992-09-09
EM DIAGNOSTIC SYSTEMS, INC.
SYSTEMATE CREATININE TEST1992-09-09
EM DIAGNOSTIC SYSTEMS, INC.
TOTAL BILIRUBIN CATALOG NO. 654071992-09-09
EM DIAGNOSTIC SYSTEMS, INC.
SYSTEMATE CALCIUM TEST TECHNICON RA 10001992-09-09
EM DIAGNOSTIC SYSTEMS, INC.
SYSTAMATE ASPARTATE AMINOTRANSFERASE TEST TECHNICO1992-09-09
EM DIAGNOSTIC SYSTEMS, INC.
SYSTEMATE DIRECT BILIRUBIN TEST TECHNICON RA 10001992-09-09
EM DIAGNOSTIC SYSTEMS, INC.
ABBOTT QUICKSTART AMYLASE, #5AXX1992-03-02
EM DIAGNOSTIC SYSTEMS, INC.
ABBOTT QUICKSTART TIGLYCERIDES REAGENT1992-01-15
EM DIAGNOSTIC SYSTEMS, INC.
ABBOTT QUICKSTART SGOT, ITEM NUMBER: 5A421992-01-03
EM DIAGNOSTIC SYSTEMS, INC.
QUICKSTART UREA NITROGEN1991-12-31
EM DIAGNOSTIC SYSTEMS, INC.
ABBOTT QUICKSTART CHOLESTEROL TEST1991-12-18
EM DIAGNOSTIC SYSTEMS, INC.
CREATINE KINASE MB TEST ITEM NUMBER 5A461991-12-13
EM DIAGNOSTIC SYSTEMS, INC.
ABBOTT QUICKSTART SGPT, ITEM NUMBER 5A431991-11-22
EM DIAGNOSTIC SYSTEMS, INC.
ABBOTT QUICKSTART TRIGLYCERIDES REAGENTS, #5A331991-11-22
EM DIAGNOSTIC SYSTEMS, INC.
ABBOTT QUICKSTART ALKA PHOSPHATASE (ALP) ITEM#5A381991-11-22
EM DIAGNOSTIC SYSTEMS, INC.
ABBOTT QUICKSTART MAGNESIUM TEST, ITEM #5A321991-11-05
EM DIAGNOSTIC SYSTEMS, INC.
ABBOTT QUICK START CREATINE KINASE(CK) ITEM #5A171991-10-31
EM DIAGNOSTIC SYSTEMS, INC.
ABBOTT QUICKSTART DIRECT BILIRUBIN (DBIL) #5A201991-10-25
EM DIAGNOSTIC SYSTEMS, INC.
ABBOTT QUICKSTART LD-1,#5A301991-10-21
EM DIAGNOSTIC SYSTEMS, INC.
ABBOTT QUICKSTART LDH,#5A311991-10-11
EM DIAGNOSTIC SYSTEMS, INC.
ABBOTT QUICKSTART TOTAL BILIRUBIN (TBIL) #5A211991-10-11
EM DIAGNOSTIC SYSTEMS, INC.
ABBOTT QLUICKSTART IRON TEST, ITEM #5A291991-10-09
EM DIAGNOSTIC SYSTEMS, INC.
ABBOTT QUICKSTART ALBUMIN BCP (ALBP)#5A161991-10-09
EM DIAGNOSTIC SYSTEMS, INC.
ABBOTT QUICKSTART ASPARATE AMINOTRANSFERASE TEST1991-10-02
EM DIAGNOSTIC SYSTEMS, INC.
ABBOTT QUICKSTART ALBUMIN TEST (ALBG) ITEM #5A371991-09-27
EM DIAGNOSTIC SYSTEMS, INC.
ABBOTT QUICKSTART URIC ACID TEST (URCA) ITEM# 5A341991-09-27
EM DIAGNOSTIC SYSTEMS, INC.
ABBOTT QUICKSTART TIBC PRETREATMENT KIT, 5A29-011991-09-19
EM DIAGNOSTIC SYSTEMS, INC.
ABBOTT QUICKSTART ALANINE AMINOTRANSFER1991-09-19
EM DIAGNOSTIC SYSTEMS, INC.
ABBOTT QUICKSTART CREATININE TEST(CREA) ITEM# 5A281991-09-18
EM DIAGNOSTIC SYSTEMS, INC.
ABBOTT QUICKSTART BICARBONATE TEST CO2 ITEM# 5A221991-09-11
EM DIAGNOSTIC SYSTEMS, INC.
ABBOTT QUICKSTART PHOSPHORUS(PHOS) ITEM #5A141991-08-12
EM DIAGNOSTIC SYSTEMS, INC.
ABBOTT QUICKSTART TOTAL PROTEIN TEST ITEM# 5A131991-07-30
EM DIAGNOSTIC SYSTEMS, INC.
ABBOTT QUICK START GLUCOSE (GLUE) ITEM# 5A151991-07-30
EM DIAGNOSTIC SYSTEMS, INC.
ABBOTT QUICKSTART GAMMA-GLUTAMYTRANSFERASE TEST1991-07-26
EM DIAGNOSTIC SYSTEMS, INC.
SYSTEMATE CREATININE (EPOS APPLICATION) #654131991-05-08
EM DIAGNOSTIC SYSTEMS, INC.
SYSTEMATE LACTATE DEHYDROGENASE (EPOS APPL) #654761991-04-12
EM DIAGNOSTIC SYSTEMS, INC.
SYSTEMATE ALKALINE PHOSPHATASE(EPOS APPL) #654831991-04-12
EM DIAGNOSTIC SYSTEMS, INC.
SYSTEMATE TRIGLYCERIIDES (EPOS APPLICATION) #654771991-03-11
EM DIAGNOSTIC SYSTEMS, INC.
OLYMPUS URINE PH CALIBRATORS LEVELS I AND II1991-02-13
EM DIAGNOSTIC SYSTEMS, INC.
SYSTEMATE TOTAL PROTEIN (EPOS APPLICATION) #654201991-01-31
EM DIAGNOSTIC SYSTEMS, INC.
SYSTEMATE ALBUMIN (EPOS APPLICATION) #654011991-01-25
EM DIAGNOSTIC SYSTEMS, INC.
SYSTEMATE CALCIUM (EPOS APPLICATION) #654091991-01-15
EM DIAGNOSTIC SYSTEMS, INC.
SYSTEMATE GGT (EPOS APPLICATION) #654141991-01-04
EM DIAGNOSTIC SYSTEMS, INC.
SYSTEMATE BICARBONATE OLYMPUS BICARBONATE1990-10-04
EM DIAGNOSTIC SYSTEMS, INC.
OLYMPUS INORGANIC PHOSPHORUS1990-09-12
EM DIAGNOSTIC SYSTEMS, INC.
ALANINE AMINOTRANSFERASE TEST1990-09-12
EM DIAGNOSTIC SYSTEMS, INC.
UREA NITROGEN TEST1990-09-07
EM DIAGNOSTIC SYSTEMS, INC.
SYSTEMATE URIC ACID (URCA) ITEM NUMBER 654221990-08-17
EM DIAGNOSTIC SYSTEMS, INC.
CREATINE KINASE TEST (CK) ITEM NUMBER 654111990-08-17
EM DIAGNOSTIC SYSTEMS, INC.
SYSTEMATE AMYLASE (AMYL) ITEM NUMBER 654041990-08-17
EM DIAGNOSTIC SYSTEMS, INC.
ASPARTATE AMINOTRANSFERASE TEST1990-08-17
EM DIAGNOSTIC SYSTEMS, INC.
CREATINE KINASE-MB TEST (MB-DS) ITEM #676551990-07-10
EM DIAGNOSTIC SYSTEMS, INC.
SYSTEMATE(TM) DIRECT BILIRUBIN CATALOG NO. 654061990-06-06
EM DIAGNOSTIC SYSTEMS, INC.
OLYMPUS(TM) TOTAL BILIRUBIN1990-05-10
EM DIAGNOSTIC SYSTEMS, INC.
OLYMPUS INORGANIC PHOSPHORUS (2-REAGENT MODIFICA.)1990-05-02
EM DIAGNOSTIC SYSTEMS, INC.
EMDS(TM) CEREBROSPINAL FLUID PROTEIN, #67668/951990-04-16

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