Em Diagnostic Systems, Inc.
Em Diagnostic Systems, Inc. holds FDA 510(k) medical device clearances, first cleared 1984, most recent 1994.
Clearances by Em Diagnostic Systems, Inc. — page 2
101–200 of 288- K900850 — EMDS CHOLESTEROL (CHO), ITEM NUMBERS 65410
- K897176 — SYSTEMATE(TM) TOTAL BILIRUBIN CATALOG NO. 654XX
- K897175 — OLYMPUS DIRECT BILIRUBIN
- K895249 — SYSTEMATE(TM) IRON ITEM NUMBER: 65417
- K895250 — SYSTEMATE(TM) ALKALINE PHOSPHATASE ITEM #65402
- K895022 — SYSTEMATE CREATININE TEST (CREA) #65413
- K895118 — SYSTEMATE TOTAL BILIRUBIN CATALOG NO. 65407
- K895119 — SYSTEMATE DIRECT BILIRUBIN CATALOG NO. 65406
- K894509 — BICARBONATE TEST ITEM NUMBER: 65412
- K894482 — LACTATE DEHYDROGENASE TEST (LD) ITEM #65418
- K894483 — GLUCOSE-HK TEST (GLU-HK) ITEM #65415
- K893778 — CALCIUM TEST ITEM NUMBER: 65409
- K893915 — EMDS TOTAL PROTEIN (TP), ITEM NUMBER 65420
- K894288 — PHOSPHORUS TEST ITEM NUMBER 65416
- K894378 — UREA NITROGEN TEST (BUN) ITEM #65408
- K894508 — MAGNESIUM TEST ITEM NUMBER: 65419
- K893916 — EMDS CHOLESTEROL (CHO), ITEM NUMBER 65410
- K893917 — EMDS TRIGLYCERIDE (TRIG), ITEM NUMBER 65421
- K894287 — URIC ACID TEST ITEM NUMBER 65422
- K893777 — ALBUMIN TEST (ALB) ITEM NUMBER: 65401
- K893751 — AMYLASE TEST (AML) ITEM NUMBER: 65404
- K891999 — CHLORIDE STANDARDS ITEM #SR1041
- K893752 — ALANINE AMINOTRANSFERASE TEST (ALT) ITEM # 65403
- K893765 — GAMMA GLUTAMYL TRANSFERASE TEST, ITEM: 65414/R1
- K891574 — LITHIUM CONCENTRATE #SR1031, NA/K STANDARDS SR1030
- K892863 — EASY-TEST IRON (IRON) ITEM NO. 16686
- K890798 — REVISED MAGNESIUM TEST ITEM NUMBER: SR1019
- K885023 — CHOLESTEROL TEST ITEM NUMBER: SR1011
- K890305 — BICARBONATE TEST ITEM NUMBER: SR1006
- K884547 — CREATINE KINASE-MB TEST (CK-MK) ITEM NUMBER 65673
- K885265 — HDL CHOLESTEROL TEST
- K890304 — IRON REAGENTS ITEM NUMBER: SR1017
- K885266 — OLYMPUS TRIGLYCERIDES REAGENTS #SR1021
- K884546 — CREATINE KINASE TEST (CK) ITEM NUMBER: 65661
- K885284 — TOTAL BILIRUBIN TEST CATALOG NO. SR1007
- K885285 — DIRECT BILIRUBIN TEST CATALOG NO. SR1008
- K884702 — EASY-TEST PARTIAL THROMBOPLASTIN TIME PTT #16629
- K884703 — TOTAL PROTEIN TEST (TP) ITEM #65670
- K884704 — URIC ACID TEST (URIC) ITEM #65620
- K885022 — MAGNESIUM TEST ITEM NUMBER: SR1019
- K884986 — CALCIUM TEST ITEM NUMBER: SR1009
- K884987 — UREA NITROGEN TEST (BUN) ITEM NUMBER: SR1022
- K884988 — GAMMA GLUTAMYL TRANSFERASE TEST (GGT) ITEM: 65664
- K884376 — ALANINE AMINOTRANSFERASE TEST ITEM NO. 65652
- K884382 — AMYLASE TEST (AMYL) ITEM NUMBER: 65653
- K884705 — ALBUMIN TEST (ALB) ITEM #65650
- K884706 — CHLORIDE TEST (CL) ITEM #65659
- K884736 — GLUCOSE-HK TEST (GLUC-HK) ITEM #65665
- K884734 — CREATININE TEST (CREA) ITEM #65663
- K884735 — PHOSPHORUS TEST (PHOS) ITEM #65666
- K884377 — ASPARTATE AMINOTRANSFERASE TEST ITEM NO. 65654
- K884021 — EMDS GLUCOSE (GLUC) TESTPACKS, NO. 67697/95
- K884548 — LACTATE DEHYDROGENASE TEST (LD) ITEM NO. 65668
- K884549 — ALKALINE PHOSPHATASE TEST (ALP) ITEM NO. 65651
- K882766 — EMDS ACETAMINOPHEN CALIBRATOR NO. 67636/95
- K882719 — EASY-TEST EMIT ACETAMINOPHEN (ACTM) NO. 16653
- K881607 — EASY-TEST EMIT(R) ETHOSUXIMIDE (ETHS) ITEM 16647
- K881229 — AUTO TROL(TM) CONTROL, LEVELS 1 & 2 #16692 & 16693
- K881337 — EMDS LIDOCAINE CALIBRATOR ITEM NO. 67XXX/95
- K880003 — ADDITIONAL ALLERGENS FOR IGE FAST-PLUS TEST
- K880339 — EASY-TEST POTASSIUM K ITEM NUMBER 19XXX
- K875062 — EASY-TEST PROTHROMBIN TIME PT ITEM NO. 16628
- K874586 — EASY-TEST ALANINE AMINOTRANSFERASE (ALAT) #19017
- K874600 — EASY-TEST ASPARTATE AMINOTRANSFERASE (ASAT) #19010
- K874705 — EASY-TEST AMYLASE (AMYL), ITEM NUMBER 19019
- K874708 — EASY-TEST GLUCOSE (GLUC), ITEM NUMBER 19008
- K874476 — EASY-TEST TOTAL PROTEIN (TP) ITEM NUMBER: 19011
- K874397 — EASY-TEST HDL CHOLESTEROL ITEM NUMBER 16683
- K874477 — EASY-TEST UREA NITROGEN (BUN) ITEM NUMBER: 19010
- K874101 — EMDS N-ACETYLPROCAINAMIDE CALIBRATOR #67635/95
- K874088 — EASY-TEST CREATININE (CREA) ITEM NO. 19009
- K874102 — EMDS PROCAINAMIDE CALIBRATOR ITEM NO. 67634/95
- K874153 — EASY-TEST PHOSPHORUS (PHOS) ITEM NO. 16687
- K873425 — EASY-TEST SALICYLATE (SAL) #16691
- K873426 — EASY-TEST EMIT(R) AMIKACIN (AMIK) NO. 16645
- K873436 — EMDS AMIKACIN CALIBRATOR ITEM NO. 67633/95
- K873635 — EASY-TEST ALKALINE PHOSPHATASE (ALP) #19021
- K873994 — EASY-TEST ALBUMIN (ALB), ITEM NO. 19039
- K873551 — CONJUGATED BILIRUBIN (CBIL) ITEM NO. 67684/95
- K873350 — EASY-TEST EMIT PROCAINAMIDE (PROC) #16648
- K873681 — ALKALINE PHOSPHATASE (ALK P) TESTPACK #67690/95
- K873349 — EASY-TEST EMIT N-ACETYLPROCAINAMIDE NAPA #16649
- K873424 — EASY-TEST CONJUGATED BILIRUBIN (CBIL) #16690
- K872321 — EMDS SALICYLATE (SAL) CALIBRATOR, NO# 67641/93
- K872512 — EMDS TOTAL BILIRUBIN (TBIL) TESTPACKS, #67675/95
- K872513 — EASY-TEST TOTAL BILIRUBIN (TBIL) ITEM NO. 16604
- K872813 — EASY ST ANALYZER SYSTEM
- K872320 — EASY-TEST GAMMA-GLUTAMYL TRANSFERASE (GGT) 16616
- K872322 — EMDS GAMMA-GLUTAMYL TRANSFERASE (GGT) 67680/95
- K872653 — EASY-TEST HEMOGLOBIN (HGB) ITEM #16685
- K872330 — EMDS SALICYLATE (SAL) TESTPACKS, ITEM NO. 67694/95
- K872110 — EASY-TEST AMMONIA (AMON) ITEM NO. 16695
- K871329 — EASY-TEST EMIT GENTAMICIN (GENT) ITEM NO. 16640
- K871638 — EASY-TEST CHEM CAL LEVELS 1,2&3/ITEMS 67617 ABC/95
- K871414 — EMDS TIBC PRETREATMENT SET ITEM NO. 67612/93
- K871330 — EMDS GENTAMICIN CALIBRATOR ITEM NO. 67628/95
- K870868 — EASY-TEST URIC ACID (URIC) #16606
- K870462 — EASY-TEST CREATINE KINASE-MB (CK-MB) #16615
- K870170 — EASY-TEST CALCIUM (CA), ITEM NO. 67528/93
- K870461 — EASY-TEST CREATINE KINASE (CK) NUMBER: 16614
Data sourced from openFDA. This site is unofficial and independent of the FDA.