Em Diagnostic Systems, Inc.
Em Diagnostic Systems, Inc. holds FDA 510(k) medical device clearances, first cleared 1984, most recent 1994.
Top product codes for Em Diagnostic Systems, Inc.
Recent clearances by Em Diagnostic Systems, Inc.
1–100 of 288- K935181 — ASPARTATE AMINOTRANSFERASE (AST) TEST
- K935180 — ALANINE AMINOTRANSFERASE (ALT) TEST
- K935178 — EMDS PHOSPHOROUS (PHOS) TEST
- K935179 — EMDS ALBUMIN (ALB) TEST
- K935136 — CHOLESTEROL (CHOL) TEST ITEM NO. 65410
- K935174 — TOTAL PROTEIN TEST (TPRO)
- K935175 — LACTATE DEHYDROGENASE (LD)
- K935176 — IRON TEST
- K935177 — GAMMA-GLUTAMYL TRANSFERASE (GGT) TEST
- K935182 — EMDS ALKANINE PHOSPHATASE (ALP) TEST
- K935183 — EMDS MAGNESIUM (MG) TEST
- K932158 — CALCIUM TEST ITEM NUMBER 65409
- K932162 — URIC ACID TEST ITEM NUMBER 65422
- K932159 — SYSTEMATE DIRECT BILIRUBIN CAT. NO. 65406
- K932161 — UREA NITROGEN TEST ITEM NUMBER 65408
- K931891 — TRIGLYCERIDES
- K931582 — ETHYLIDENE AMYL
- K931583 — SILYL AMYL
- K931887 — BICARBONATE
- K931888 — TOTAL BILIRUBIN
- K931889 — CREATINE KINASE TEST
- K931890 — GLUCOSE-HK TEST
- K932160 — SYSTEMATE CREATININE TEST ITEM NUMBER 65413
- K930166 — IRON TEST #'S 42376/93,42324/R1A,42324/R1B,42324/R
- K925101 — SYSTEMATE PLUS CALIBRATOR
- K924703 — LACTATE DEHYDROGENASE (LD) TEST ITEM #65418
- K925188 — ABBOTT QUICKSTART LD-1, MODIFICATION
- K924508 — CHOLESTEROL TEST ITEM# 42374/93, 42322/R1
- K924710 — TRIGLYCERIDES
- K925002 — UREA NITROGEN TEST
- K923959 — ALBUMIN TEST
- K924711 — BICARBONATE
- K924572 — EMDS GLUCOSE (GLU-HK) TEST, ITEM 65415
- K924574 — EMDS ALKALINE PHOSPHATASE (ALP) TEST
- K924573 — SYSTEMATE PLUS TRIGLYCERIDE-GLYCEROL BLANKED TEST
- K923733 — CHOLESTEROL TEST
- K924599 — CREATININE-IP TEST, # 42375/93, 42323/R1, 42323/R2
- K924470 — TWO PART INORGANIC PHOSPHORUS TEST
- K924704 — CREATINE KINASE (CK) TEST ITEM #65411
- K922947 — GAMMA GULTAMYL TRANSFERASE TEST
- K923257 — EMDS ALANINE AMINOTRANSFER TEST(ALT) TECH RA 1000
- K923764 — SYSTEMATE PHOSPHORUS TEST TECHNICON RA 1000
- K923765 — SYSTEMATE URICACID TEST, TECHNICON RA 1000
- K922856 — SYSTEMATE DIRECT BILIRUBIN TEST TECHNICON RA 1000
- K922857 — SYSTAMATE ASPARTATE AMINOTRANSFERASE TEST TECHNICO
- K922953 — SYSTEMATE CALCIUM TEST TECHNICON RA 1000
- K923083 — TOTAL BILIRUBIN CATALOG NO. 65407
- K923203 — SYSTEMATE CREATININE TEST
- K923267 — SYSTEMATE TOTAL PROTEIN TEST, TECHNICON RA 1000
- K923677 — AMYLASE TEST
- K920583 — ABBOTT QUICKSTART AMYLASE, #5AXX
- K915732 — ABBOTT QUICKSTART TIGLYCERIDES REAGENT
- K914463 — ABBOTT QUICKSTART SGOT, ITEM NUMBER: 5A42
- K914903 — QUICKSTART UREA NITROGEN
- K913565 — ABBOTT QUICKSTART CHOLESTEROL TEST
- K914361 — CREATINE KINASE MB TEST ITEM NUMBER 5A46
- K913921 — ABBOTT QUICKSTART ALKA PHOSPHATASE (ALP) ITEM#5A38
- K914018 — ABBOTT QUICKSTART TRIGLYCERIDES REAGENTS, #5A33
- K914464 — ABBOTT QUICKSTART SGPT, ITEM NUMBER 5A43
- K913764 — ABBOTT QUICKSTART MAGNESIUM TEST, ITEM #5A32
- K912807 — ABBOTT QUICK START CREATINE KINASE(CK) ITEM #5A17
- K913466 — ABBOTT QUICKSTART DIRECT BILIRUBIN (DBIL) #5A20
- K914261 — ABBOTT QUICKSTART LD-1,#5A30
- K913307 — ABBOTT QUICKSTART TOTAL BILIRUBIN (TBIL) #5A21
- K914262 — ABBOTT QUICKSTART LDH,#5A31
- K913025 — ABBOTT QUICKSTART ALBUMIN BCP (ALBP)#5A16
- K913705 — ABBOTT QLUICKSTART IRON TEST, ITEM #5A29
- K914068 — ABBOTT QUICKSTART ASPARATE AMINOTRANSFERASE TEST
- K913706 — ABBOTT QUICKSTART URIC ACID TEST (URCA) ITEM# 5A34
- K913920 — ABBOTT QUICKSTART ALBUMIN TEST (ALBG) ITEM #5A37
- K913846 — ABBOTT QUICKSTART ALANINE AMINOTRANSFER
- K913922 — ABBOTT QUICKSTART TIBC PRETREATMENT KIT, 5A29-01
- K913707 — ABBOTT QUICKSTART CREATININE TEST(CREA) ITEM# 5A28
- K912806 — ABBOTT QUICKSTART BICARBONATE TEST CO2 ITEM# 5A22
- K912809 — ABBOTT QUICKSTART PHOSPHORUS(PHOS) ITEM #5A14
- K912808 — ABBOTT QUICK START GLUCOSE (GLUE) ITEM# 5A15
- K912810 — ABBOTT QUICKSTART TOTAL PROTEIN TEST ITEM# 5A13
- K913024 — ABBOTT QUICKSTART GAMMA-GLUTAMYTRANSFERASE TEST
- K905658 — SYSTEMATE CREATININE (EPOS APPLICATION) #65413
- K910639 — SYSTEMATE ALKALINE PHOSPHATASE(EPOS APPL) #65483
- K910640 — SYSTEMATE LACTATE DEHYDROGENASE (EPOS APPL) #65476
- K910638 — SYSTEMATE TRIGLYCERIIDES (EPOS APPLICATION) #65477
- K905477 — OLYMPUS URINE PH CALIBRATORS LEVELS I AND II
- K905661 — SYSTEMATE TOTAL PROTEIN (EPOS APPLICATION) #65420
- K905660 — SYSTEMATE ALBUMIN (EPOS APPLICATION) #65401
- K905659 — SYSTEMATE CALCIUM (EPOS APPLICATION) #65409
- K905662 — SYSTEMATE GGT (EPOS APPLICATION) #65414
- K903409 — SYSTEMATE BICARBONATE OLYMPUS BICARBONATE
- K903198 — ALANINE AMINOTRANSFERASE TEST
- K903696 — OLYMPUS INORGANIC PHOSPHORUS
- K903334 — UREA NITROGEN TEST
- K903197 — ASPARTATE AMINOTRANSFERASE TEST
- K903332 — SYSTEMATE AMYLASE (AMYL) ITEM NUMBER 65404
- K903333 — CREATINE KINASE TEST (CK) ITEM NUMBER 65411
- K903335 — SYSTEMATE URIC ACID (URCA) ITEM NUMBER 65422
- K902483 — CREATINE KINASE-MB TEST (MB-DS) ITEM #67655
- K902123 — SYSTEMATE(TM) DIRECT BILIRUBIN CATALOG NO. 65406
- K897174 — OLYMPUS(TM) TOTAL BILIRUBIN
- K901807 — OLYMPUS INORGANIC PHOSPHORUS (2-REAGENT MODIFICA.)
- K901083 — EMDS(TM) CEREBROSPINAL FLUID PROTEIN, #67668/95
Data sourced from openFDA. This site is unofficial and independent of the FDA.