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Em Diagnostic Systems, Inc.

288 FDA 510(k) clearances · Manufacturer

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RecordFirmDate
ASPARTATE AMINOTRANSFERASE (AST) TEST (K935181)Em Diagnostic Systems, Inc.1994-01-27
ALANINE AMINOTRANSFERASE (ALT) TEST (K935180)Em Diagnostic Systems, Inc.1994-01-13
EMDS PHOSPHOROUS (PHOS) TEST (K935178)Em Diagnostic Systems, Inc.1993-12-17
EMDS ALBUMIN (ALB) TEST (K935179)Em Diagnostic Systems, Inc.1993-12-17
CHOLESTEROL (CHOL) TEST ITEM NO. 65410 (K935136)Em Diagnostic Systems, Inc.1993-12-16
TOTAL PROTEIN TEST (TPRO) (K935174)Em Diagnostic Systems, Inc.1993-12-16
IRON TEST (K935176)Em Diagnostic Systems, Inc.1993-12-16
GAMMA-GLUTAMYL TRANSFERASE (GGT) TEST (K935177)Em Diagnostic Systems, Inc.1993-12-16
LACTATE DEHYDROGENASE (LD) (K935175)Em Diagnostic Systems, Inc.1993-12-16
EMDS MAGNESIUM (MG) TEST (K935183)Em Diagnostic Systems, Inc.1993-12-09
EMDS ALKANINE PHOSPHATASE (ALP) TEST (K935182)Em Diagnostic Systems, Inc.1993-12-09
CALCIUM TEST ITEM NUMBER 65409 (K932158)Em Diagnostic Systems, Inc.1993-09-27
URIC ACID TEST ITEM NUMBER 65422 (K932162)Em Diagnostic Systems, Inc.1993-09-27
SYSTEMATE DIRECT BILIRUBIN CAT. NO. 65406 (K932159)Em Diagnostic Systems, Inc.1993-09-21
UREA NITROGEN TEST ITEM NUMBER 65408 (K932161)Em Diagnostic Systems, Inc.1993-09-08
TRIGLYCERIDES (K931891)Em Diagnostic Systems, Inc.1993-08-25
SILYL AMYL (K931583)Em Diagnostic Systems, Inc.1993-08-19
ETHYLIDENE AMYL (K931582)Em Diagnostic Systems, Inc.1993-08-19
BICARBONATE (K931887)Em Diagnostic Systems, Inc.1993-08-03
CREATINE KINASE TEST (K931889)Em Diagnostic Systems, Inc.1993-07-27
TOTAL BILIRUBIN (K931888)Em Diagnostic Systems, Inc.1993-07-27
GLUCOSE-HK TEST (K931890)Em Diagnostic Systems, Inc.1993-07-22
SYSTEMATE CREATININE TEST ITEM NUMBER 65413 (K932160)Em Diagnostic Systems, Inc.1993-07-09
IRON TEST #'S 42376/93,42324/R1A,42324/R1B,42324/R (K930166)Em Diagnostic Systems, Inc.1993-04-21
SYSTEMATE PLUS CALIBRATOR (K925101)Em Diagnostic Systems, Inc.1993-02-23
LACTATE DEHYDROGENASE (LD) TEST ITEM #65418 (K924703)Em Diagnostic Systems, Inc.1993-02-05
ABBOTT QUICKSTART LD-1, MODIFICATION (K925188)Em Diagnostic Systems, Inc.1993-02-05
CHOLESTEROL TEST ITEM# 42374/93, 42322/R1 (K924508)Em Diagnostic Systems, Inc.1993-01-28
TRIGLYCERIDES (K924710)Em Diagnostic Systems, Inc.1993-01-26
UREA NITROGEN TEST (K925002)Em Diagnostic Systems, Inc.1993-01-04
ALBUMIN TEST (K923959)Em Diagnostic Systems, Inc.1992-12-28
BICARBONATE (K924711)Em Diagnostic Systems, Inc.1992-12-03
EMDS GLUCOSE (GLU-HK) TEST, ITEM 65415 (K924572)Em Diagnostic Systems, Inc.1992-11-25
EMDS ALKALINE PHOSPHATASE (ALP) TEST (K924574)Em Diagnostic Systems, Inc.1992-11-09
SYSTEMATE PLUS TRIGLYCERIDE-GLYCEROL BLANKED TEST (K924573)Em Diagnostic Systems, Inc.1992-11-06
CHOLESTEROL TEST (K923733)Em Diagnostic Systems, Inc.1992-10-26
CREATININE-IP TEST, # 42375/93, 42323/R1, 42323/R2 (K924599)Em Diagnostic Systems, Inc.1992-10-15
TWO PART INORGANIC PHOSPHORUS TEST (K924470)Em Diagnostic Systems, Inc.1992-10-14
CREATINE KINASE (CK) TEST ITEM #65411 (K924704)Em Diagnostic Systems, Inc.1992-10-13
EMDS ALANINE AMINOTRANSFER TEST(ALT) TECH RA 1000 (K923257)Em Diagnostic Systems, Inc.1992-09-28
GAMMA GULTAMYL TRANSFERASE TEST (K922947)Em Diagnostic Systems, Inc.1992-09-28
SYSTEMATE URICACID TEST, TECHNICON RA 1000 (K923765)Em Diagnostic Systems, Inc.1992-09-22
SYSTEMATE PHOSPHORUS TEST TECHNICON RA 1000 (K923764)Em Diagnostic Systems, Inc.1992-09-22
SYSTEMATE CALCIUM TEST TECHNICON RA 1000 (K922953)Em Diagnostic Systems, Inc.1992-09-09
SYSTAMATE ASPARTATE AMINOTRANSFERASE TEST TECHNICO (K922857)Em Diagnostic Systems, Inc.1992-09-09
TOTAL BILIRUBIN CATALOG NO. 65407 (K923083)Em Diagnostic Systems, Inc.1992-09-09
SYSTEMATE CREATININE TEST (K923203)Em Diagnostic Systems, Inc.1992-09-09
SYSTEMATE TOTAL PROTEIN TEST, TECHNICON RA 1000 (K923267)Em Diagnostic Systems, Inc.1992-09-09
AMYLASE TEST (K923677)Em Diagnostic Systems, Inc.1992-09-09
SYSTEMATE DIRECT BILIRUBIN TEST TECHNICON RA 1000 (K922856)Em Diagnostic Systems, Inc.1992-09-09
ABBOTT QUICKSTART AMYLASE, #5AXX (K920583)Em Diagnostic Systems, Inc.1992-03-02
ABBOTT QUICKSTART TIGLYCERIDES REAGENT (K915732)Em Diagnostic Systems, Inc.1992-01-15
ABBOTT QUICKSTART SGOT, ITEM NUMBER: 5A42 (K914463)Em Diagnostic Systems, Inc.1992-01-03
QUICKSTART UREA NITROGEN (K914903)Em Diagnostic Systems, Inc.1991-12-31
ABBOTT QUICKSTART CHOLESTEROL TEST (K913565)Em Diagnostic Systems, Inc.1991-12-18
CREATINE KINASE MB TEST ITEM NUMBER 5A46 (K914361)Em Diagnostic Systems, Inc.1991-12-13
ABBOTT QUICKSTART TRIGLYCERIDES REAGENTS, #5A33 (K914018)Em Diagnostic Systems, Inc.1991-11-22
ABBOTT QUICKSTART ALKA PHOSPHATASE (ALP) ITEM#5A38 (K913921)Em Diagnostic Systems, Inc.1991-11-22
ABBOTT QUICKSTART SGPT, ITEM NUMBER 5A43 (K914464)Em Diagnostic Systems, Inc.1991-11-22
ABBOTT QUICKSTART MAGNESIUM TEST, ITEM #5A32 (K913764)Em Diagnostic Systems, Inc.1991-11-05
ABBOTT QUICK START CREATINE KINASE(CK) ITEM #5A17 (K912807)Em Diagnostic Systems, Inc.1991-10-31
ABBOTT QUICKSTART DIRECT BILIRUBIN (DBIL) #5A20 (K913466)Em Diagnostic Systems, Inc.1991-10-25
ABBOTT QUICKSTART LD-1,#5A30 (K914261)Em Diagnostic Systems, Inc.1991-10-21
ABBOTT QUICKSTART TOTAL BILIRUBIN (TBIL) #5A21 (K913307)Em Diagnostic Systems, Inc.1991-10-11
ABBOTT QUICKSTART LDH,#5A31 (K914262)Em Diagnostic Systems, Inc.1991-10-11
ABBOTT QUICKSTART ALBUMIN BCP (ALBP)#5A16 (K913025)Em Diagnostic Systems, Inc.1991-10-09
ABBOTT QLUICKSTART IRON TEST, ITEM #5A29 (K913705)Em Diagnostic Systems, Inc.1991-10-09
ABBOTT QUICKSTART ASPARATE AMINOTRANSFERASE TEST (K914068)Em Diagnostic Systems, Inc.1991-10-02
ABBOTT QUICKSTART ALBUMIN TEST (ALBG) ITEM #5A37 (K913920)Em Diagnostic Systems, Inc.1991-09-27
ABBOTT QUICKSTART URIC ACID TEST (URCA) ITEM# 5A34 (K913706)Em Diagnostic Systems, Inc.1991-09-27
ABBOTT QUICKSTART ALANINE AMINOTRANSFER (K913846)Em Diagnostic Systems, Inc.1991-09-19
ABBOTT QUICKSTART TIBC PRETREATMENT KIT, 5A29-01 (K913922)Em Diagnostic Systems, Inc.1991-09-19
ABBOTT QUICKSTART CREATININE TEST(CREA) ITEM# 5A28 (K913707)Em Diagnostic Systems, Inc.1991-09-18
ABBOTT QUICKSTART BICARBONATE TEST CO2 ITEM# 5A22 (K912806)Em Diagnostic Systems, Inc.1991-09-11
ABBOTT QUICKSTART PHOSPHORUS(PHOS) ITEM #5A14 (K912809)Em Diagnostic Systems, Inc.1991-08-12
ABBOTT QUICK START GLUCOSE (GLUE) ITEM# 5A15 (K912808)Em Diagnostic Systems, Inc.1991-07-30
ABBOTT QUICKSTART TOTAL PROTEIN TEST ITEM# 5A13 (K912810)Em Diagnostic Systems, Inc.1991-07-30
ABBOTT QUICKSTART GAMMA-GLUTAMYTRANSFERASE TEST (K913024)Em Diagnostic Systems, Inc.1991-07-26
SYSTEMATE CREATININE (EPOS APPLICATION) #65413 (K905658)Em Diagnostic Systems, Inc.1991-05-08
SYSTEMATE ALKALINE PHOSPHATASE(EPOS APPL) #65483 (K910639)Em Diagnostic Systems, Inc.1991-04-12
SYSTEMATE LACTATE DEHYDROGENASE (EPOS APPL) #65476 (K910640)Em Diagnostic Systems, Inc.1991-04-12
SYSTEMATE TRIGLYCERIIDES (EPOS APPLICATION) #65477 (K910638)Em Diagnostic Systems, Inc.1991-03-11
OLYMPUS URINE PH CALIBRATORS LEVELS I AND II (K905477)Em Diagnostic Systems, Inc.1991-02-13
SYSTEMATE TOTAL PROTEIN (EPOS APPLICATION) #65420 (K905661)Em Diagnostic Systems, Inc.1991-01-31
SYSTEMATE ALBUMIN (EPOS APPLICATION) #65401 (K905660)Em Diagnostic Systems, Inc.1991-01-25
SYSTEMATE CALCIUM (EPOS APPLICATION) #65409 (K905659)Em Diagnostic Systems, Inc.1991-01-15
SYSTEMATE GGT (EPOS APPLICATION) #65414 (K905662)Em Diagnostic Systems, Inc.1991-01-04
SYSTEMATE BICARBONATE OLYMPUS BICARBONATE (K903409)Em Diagnostic Systems, Inc.1990-10-04
ALANINE AMINOTRANSFERASE TEST (K903198)Em Diagnostic Systems, Inc.1990-09-12
OLYMPUS INORGANIC PHOSPHORUS (K903696)Em Diagnostic Systems, Inc.1990-09-12
UREA NITROGEN TEST (K903334)Em Diagnostic Systems, Inc.1990-09-07
SYSTEMATE AMYLASE (AMYL) ITEM NUMBER 65404 (K903332)Em Diagnostic Systems, Inc.1990-08-17
ASPARTATE AMINOTRANSFERASE TEST (K903197)Em Diagnostic Systems, Inc.1990-08-17
SYSTEMATE URIC ACID (URCA) ITEM NUMBER 65422 (K903335)Em Diagnostic Systems, Inc.1990-08-17
CREATINE KINASE TEST (CK) ITEM NUMBER 65411 (K903333)Em Diagnostic Systems, Inc.1990-08-17
CREATINE KINASE-MB TEST (MB-DS) ITEM #67655 (K902483)Em Diagnostic Systems, Inc.1990-07-10
SYSTEMATE(TM) DIRECT BILIRUBIN CATALOG NO. 65406 (K902123)Em Diagnostic Systems, Inc.1990-06-06
OLYMPUS(TM) TOTAL BILIRUBIN (K897174)Em Diagnostic Systems, Inc.1990-05-10
OLYMPUS INORGANIC PHOSPHORUS (2-REAGENT MODIFICA.) (K901807)Em Diagnostic Systems, Inc.1990-05-02
EMDS(TM) CEREBROSPINAL FLUID PROTEIN, #67668/95 (K901083)Em Diagnostic Systems, Inc.1990-04-16
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