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Em Diagnostic Systems, Inc.

288 FDA 510(k) clearances · Manufacturer

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RecordFirmDate
EMDS CHOLESTEROL (CHO), ITEM NUMBERS 65410 (K900850)Em Diagnostic Systems, Inc.1990-03-29
SYSTEMATE(TM) TOTAL BILIRUBIN CATALOG NO. 654XX (K897176)Em Diagnostic Systems, Inc.1990-03-19
OLYMPUS DIRECT BILIRUBIN (K897175)Em Diagnostic Systems, Inc.1990-03-15
SYSTEMATE(TM) IRON ITEM NUMBER: 65417 (K895249)Em Diagnostic Systems, Inc.1989-10-31
SYSTEMATE(TM) ALKALINE PHOSPHATASE ITEM #65402 (K895250)Em Diagnostic Systems, Inc.1989-10-31
SYSTEMATE CREATININE TEST (CREA) #65413 (K895022)Em Diagnostic Systems, Inc.1989-10-23
SYSTEMATE DIRECT BILIRUBIN CATALOG NO. 65406 (K895119)Em Diagnostic Systems, Inc.1989-10-17
SYSTEMATE TOTAL BILIRUBIN CATALOG NO. 65407 (K895118)Em Diagnostic Systems, Inc.1989-10-17
BICARBONATE TEST ITEM NUMBER: 65412 (K894509)Em Diagnostic Systems, Inc.1989-09-15
LACTATE DEHYDROGENASE TEST (LD) ITEM #65418 (K894482)Em Diagnostic Systems, Inc.1989-09-07
GLUCOSE-HK TEST (GLU-HK) ITEM #65415 (K894483)Em Diagnostic Systems, Inc.1989-09-07
CALCIUM TEST ITEM NUMBER: 65409 (K893778)Em Diagnostic Systems, Inc.1989-09-05
EMDS TOTAL PROTEIN (TP), ITEM NUMBER 65420 (K893915)Em Diagnostic Systems, Inc.1989-08-31
PHOSPHORUS TEST ITEM NUMBER 65416 (K894288)Em Diagnostic Systems, Inc.1989-08-31
UREA NITROGEN TEST (BUN) ITEM #65408 (K894378)Em Diagnostic Systems, Inc.1989-08-31
MAGNESIUM TEST ITEM NUMBER: 65419 (K894508)Em Diagnostic Systems, Inc.1989-08-31
EMDS TRIGLYCERIDE (TRIG), ITEM NUMBER 65421 (K893917)Em Diagnostic Systems, Inc.1989-08-28
EMDS CHOLESTEROL (CHO), ITEM NUMBER 65410 (K893916)Em Diagnostic Systems, Inc.1989-08-28
URIC ACID TEST ITEM NUMBER 65422 (K894287)Em Diagnostic Systems, Inc.1989-08-28
ALBUMIN TEST (ALB) ITEM NUMBER: 65401 (K893777)Em Diagnostic Systems, Inc.1989-08-21
AMYLASE TEST (AML) ITEM NUMBER: 65404 (K893751)Em Diagnostic Systems, Inc.1989-08-17
CHLORIDE STANDARDS ITEM #SR1041 (K891999)Em Diagnostic Systems, Inc.1989-08-15
ALANINE AMINOTRANSFERASE TEST (ALT) ITEM # 65403 (K893752)Em Diagnostic Systems, Inc.1989-07-20
GAMMA GLUTAMYL TRANSFERASE TEST, ITEM: 65414/R1 (K893765)Em Diagnostic Systems, Inc.1989-07-20
LITHIUM CONCENTRATE #SR1031, NA/K STANDARDS SR1030 (K891574)Em Diagnostic Systems, Inc.1989-06-09
EASY-TEST IRON (IRON) ITEM NO. 16686 (K892863)Em Diagnostic Systems, Inc.1989-06-07
REVISED MAGNESIUM TEST ITEM NUMBER: SR1019 (K890798)Em Diagnostic Systems, Inc.1989-03-31
CHOLESTEROL TEST ITEM NUMBER: SR1011 (K885023)Em Diagnostic Systems, Inc.1989-02-17
BICARBONATE TEST ITEM NUMBER: SR1006 (K890305)Em Diagnostic Systems, Inc.1989-02-17
HDL CHOLESTEROL TEST (K885265)Em Diagnostic Systems, Inc.1989-02-10
CREATINE KINASE-MB TEST (CK-MK) ITEM NUMBER 65673 (K884547)Em Diagnostic Systems, Inc.1989-02-10
IRON REAGENTS ITEM NUMBER: SR1017 (K890304)Em Diagnostic Systems, Inc.1989-02-10
OLYMPUS TRIGLYCERIDES REAGENTS #SR1021 (K885266)Em Diagnostic Systems, Inc.1989-02-07
CREATINE KINASE TEST (CK) ITEM NUMBER: 65661 (K884546)Em Diagnostic Systems, Inc.1989-02-02
TOTAL BILIRUBIN TEST CATALOG NO. SR1007 (K885284)Em Diagnostic Systems, Inc.1989-01-30
DIRECT BILIRUBIN TEST CATALOG NO. SR1008 (K885285)Em Diagnostic Systems, Inc.1989-01-30
EASY-TEST PARTIAL THROMBOPLASTIN TIME PTT #16629 (K884702)Em Diagnostic Systems, Inc.1989-01-27
URIC ACID TEST (URIC) ITEM #65620 (K884704)Em Diagnostic Systems, Inc.1989-01-23
TOTAL PROTEIN TEST (TP) ITEM #65670 (K884703)Em Diagnostic Systems, Inc.1989-01-23
MAGNESIUM TEST ITEM NUMBER: SR1019 (K885022)Em Diagnostic Systems, Inc.1989-01-17
CALCIUM TEST ITEM NUMBER: SR1009 (K884986)Em Diagnostic Systems, Inc.1989-01-13
UREA NITROGEN TEST (BUN) ITEM NUMBER: SR1022 (K884987)Em Diagnostic Systems, Inc.1989-01-13
GAMMA GLUTAMYL TRANSFERASE TEST (GGT) ITEM: 65664 (K884988)Em Diagnostic Systems, Inc.1989-01-13
CHLORIDE TEST (CL) ITEM #65659 (K884706)Em Diagnostic Systems, Inc.1989-01-11
AMYLASE TEST (AMYL) ITEM NUMBER: 65653 (K884382)Em Diagnostic Systems, Inc.1989-01-11
ALBUMIN TEST (ALB) ITEM #65650 (K884705)Em Diagnostic Systems, Inc.1989-01-11
ALANINE AMINOTRANSFERASE TEST ITEM NO. 65652 (K884376)Em Diagnostic Systems, Inc.1989-01-11
GLUCOSE-HK TEST (GLUC-HK) ITEM #65665 (K884736)Em Diagnostic Systems, Inc.1989-01-03
CREATININE TEST (CREA) ITEM #65663 (K884734)Em Diagnostic Systems, Inc.1988-12-19
PHOSPHORUS TEST (PHOS) ITEM #65666 (K884735)Em Diagnostic Systems, Inc.1988-12-16
ASPARTATE AMINOTRANSFERASE TEST ITEM NO. 65654 (K884377)Em Diagnostic Systems, Inc.1988-12-14
LACTATE DEHYDROGENASE TEST (LD) ITEM NO. 65668 (K884548)Em Diagnostic Systems, Inc.1988-11-10
ALKALINE PHOSPHATASE TEST (ALP) ITEM NO. 65651 (K884549)Em Diagnostic Systems, Inc.1988-11-10
EMDS GLUCOSE (GLUC) TESTPACKS, NO. 67697/95 (K884021)Em Diagnostic Systems, Inc.1988-11-10
EMDS ACETAMINOPHEN CALIBRATOR NO. 67636/95 (K882766)Em Diagnostic Systems, Inc.1988-08-23
EASY-TEST EMIT ACETAMINOPHEN (ACTM) NO. 16653 (K882719)Em Diagnostic Systems, Inc.1988-08-08
EASY-TEST EMIT(R) ETHOSUXIMIDE (ETHS) ITEM 16647 (K881607)Em Diagnostic Systems, Inc.1988-06-01
AUTO TROL(TM) CONTROL, LEVELS 1 & 2 #16692 & 16693 (K881229)Em Diagnostic Systems, Inc.1988-05-27
EMDS LIDOCAINE CALIBRATOR ITEM NO. 67XXX/95 (K881337)Em Diagnostic Systems, Inc.1988-05-27
ADDITIONAL ALLERGENS FOR IGE FAST-PLUS TEST (K880003)Em Diagnostic Systems, Inc.1988-03-11
EASY-TEST POTASSIUM K ITEM NUMBER 19XXX (K880339)Em Diagnostic Systems, Inc.1988-02-25
EASY-TEST PROTHROMBIN TIME PT ITEM NO. 16628 (K875062)Em Diagnostic Systems, Inc.1988-02-11
EASY-TEST ALANINE AMINOTRANSFERASE (ALAT) #19017 (K874586)Em Diagnostic Systems, Inc.1988-01-21
EASY-TEST ASPARTATE AMINOTRANSFERASE (ASAT) #19010 (K874600)Em Diagnostic Systems, Inc.1988-01-21
EASY-TEST AMYLASE (AMYL), ITEM NUMBER 19019 (K874705)Em Diagnostic Systems, Inc.1987-12-22
EASY-TEST GLUCOSE (GLUC), ITEM NUMBER 19008 (K874708)Em Diagnostic Systems, Inc.1987-12-18
EASY-TEST TOTAL PROTEIN (TP) ITEM NUMBER: 19011 (K874476)Em Diagnostic Systems, Inc.1987-11-25
EASY-TEST HDL CHOLESTEROL ITEM NUMBER 16683 (K874397)Em Diagnostic Systems, Inc.1987-11-24
EASY-TEST UREA NITROGEN (BUN) ITEM NUMBER: 19010 (K874477)Em Diagnostic Systems, Inc.1987-11-23
EMDS N-ACETYLPROCAINAMIDE CALIBRATOR #67635/95 (K874101)Em Diagnostic Systems, Inc.1987-11-09
EASY-TEST CREATININE (CREA) ITEM NO. 19009 (K874088)Em Diagnostic Systems, Inc.1987-11-06
EMDS PROCAINAMIDE CALIBRATOR ITEM NO. 67634/95 (K874102)Em Diagnostic Systems, Inc.1987-11-05
EASY-TEST PHOSPHORUS (PHOS) ITEM NO. 16687 (K874153)Em Diagnostic Systems, Inc.1987-11-04
EASY-TEST SALICYLATE (SAL) #16691 (K873425)Em Diagnostic Systems, Inc.1987-10-29
EASY-TEST ALBUMIN (ALB), ITEM NO. 19039 (K873994)Em Diagnostic Systems, Inc.1987-10-29
EASY-TEST ALKALINE PHOSPHATASE (ALP) #19021 (K873635)Em Diagnostic Systems, Inc.1987-10-29
EASY-TEST EMIT(R) AMIKACIN (AMIK) NO. 16645 (K873426)Em Diagnostic Systems, Inc.1987-10-29
EMDS AMIKACIN CALIBRATOR ITEM NO. 67633/95 (K873436)Em Diagnostic Systems, Inc.1987-10-29
CONJUGATED BILIRUBIN (CBIL) ITEM NO. 67684/95 (K873551)Em Diagnostic Systems, Inc.1987-10-02
EASY-TEST EMIT PROCAINAMIDE (PROC) #16648 (K873350)Em Diagnostic Systems, Inc.1987-09-29
ALKALINE PHOSPHATASE (ALK P) TESTPACK #67690/95 (K873681)Em Diagnostic Systems, Inc.1987-09-29
EASY-TEST EMIT N-ACETYLPROCAINAMIDE NAPA #16649 (K873349)Em Diagnostic Systems, Inc.1987-09-22
EASY-TEST CONJUGATED BILIRUBIN (CBIL) #16690 (K873424)Em Diagnostic Systems, Inc.1987-09-14
EMDS SALICYLATE (SAL) CALIBRATOR, NO# 67641/93 (K872321)Em Diagnostic Systems, Inc.1987-08-28
EASY-TEST TOTAL BILIRUBIN (TBIL) ITEM NO. 16604 (K872513)Em Diagnostic Systems, Inc.1987-08-21
EMDS TOTAL BILIRUBIN (TBIL) TESTPACKS, #67675/95 (K872512)Em Diagnostic Systems, Inc.1987-08-21
EASY ST ANALYZER SYSTEM (K872813)Em Diagnostic Systems, Inc.1987-08-13
EASY-TEST GAMMA-GLUTAMYL TRANSFERASE (GGT) 16616 (K872320)Em Diagnostic Systems, Inc.1987-07-27
EMDS GAMMA-GLUTAMYL TRANSFERASE (GGT) 67680/95 (K872322)Em Diagnostic Systems, Inc.1987-07-27
EASY-TEST HEMOGLOBIN (HGB) ITEM #16685 (K872653)Em Diagnostic Systems, Inc.1987-07-23
EMDS SALICYLATE (SAL) TESTPACKS, ITEM NO. 67694/95 (K872330)Em Diagnostic Systems, Inc.1987-07-09
EASY-TEST AMMONIA (AMON) ITEM NO. 16695 (K872110)Em Diagnostic Systems, Inc.1987-07-01
EASY-TEST EMIT GENTAMICIN (GENT) ITEM NO. 16640 (K871329)Em Diagnostic Systems, Inc.1987-05-12
EASY-TEST CHEM CAL LEVELS 1,2&3/ITEMS 67617 ABC/95 (K871638)Em Diagnostic Systems, Inc.1987-05-12
EMDS TIBC PRETREATMENT SET ITEM NO. 67612/93 (K871414)Em Diagnostic Systems, Inc.1987-04-23
EMDS GENTAMICIN CALIBRATOR ITEM NO. 67628/95 (K871330)Em Diagnostic Systems, Inc.1987-04-22
EASY-TEST URIC ACID (URIC) #16606 (K870868)Em Diagnostic Systems, Inc.1987-03-19
EASY-TEST CREATINE KINASE-MB (CK-MB) #16615 (K870462)Em Diagnostic Systems, Inc.1987-03-10
EASY-TEST CREATINE KINASE (CK) NUMBER: 16614 (K870461)Em Diagnostic Systems, Inc.1987-03-06
EASY-TEST CALCIUM (CA), ITEM NO. 67528/93 (K870170)Em Diagnostic Systems, Inc.1987-03-06
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