Medical Device Manufacturer · US , Walker , MI

Em Diagnostic Systems, Inc. - FDA 510(k) Cleared Devices

288 submissions · 288 cleared · Since 1984
288
Total
288
Cleared
0
Denied
288 devices
176-200 of 288
Cleared Oct 29, 1987
EMDS AMIKACIN CALIBRATOR ITEM NO. 67633/95
K873436 · DLJ
Chemistry · 63d
Cleared Oct 29, 1987
EASY-TEST ALKALINE PHOSPHATASE (ALP) #19021
K873635 · CJE
Chemistry · 50d
Cleared Oct 29, 1987
EASY-TEST ALBUMIN (ALB), ITEM NO. 19039
K873994 · CIX
Chemistry · 28d
Cleared Oct 02, 1987
CONJUGATED BILIRUBIN (CBIL) ITEM NO. 67684/95
K873551 · CIG
Chemistry · 32d
Cleared Sep 29, 1987
EASY-TEST EMIT PROCAINAMIDE (PROC) #16648
K873350 · LAR
Toxicology · 40d
Cleared Sep 29, 1987
ALKALINE PHOSPHATASE (ALK P) TESTPACK #67690/95
K873681 · CJE
Chemistry · 15d
Cleared Sep 22, 1987
EASY-TEST EMIT N-ACETYLPROCAINAMIDE NAPA #16649
K873349 · LAN
Toxicology · 33d
Cleared Sep 14, 1987
EASY-TEST CONJUGATED BILIRUBIN (CBIL) #16690
K873424 · CIG
Chemistry · 20d
Cleared Aug 28, 1987
EMDS SALICYLATE (SAL) CALIBRATOR, NO# 67641/93
K872321 · DKJ
Chemistry · 72d
Cleared Aug 21, 1987
EMDS TOTAL BILIRUBIN (TBIL) TESTPACKS, #67675/95
K872512 · CIG
Chemistry · 58d
Cleared Aug 21, 1987
EASY-TEST TOTAL BILIRUBIN (TBIL) ITEM NO. 16604
K872513 · CIG
Chemistry · 58d
Cleared Aug 13, 1987
EASY ST ANALYZER SYSTEM
K872813 · JJE
Chemistry · 28d
Cleared Jul 27, 1987
EASY-TEST GAMMA-GLUTAMYL TRANSFERASE (GGT) 16616
K872320 · JQB
Chemistry · 40d
Cleared Jul 27, 1987
EMDS GAMMA-GLUTAMYL TRANSFERASE (GGT) 67680/95
K872322 · JQB
Chemistry · 40d
Cleared Jul 23, 1987
EASY-TEST HEMOGLOBIN (HGB) ITEM #16685
K872653 · KHG
Hematology · 16d
Cleared Jul 09, 1987
EMDS SALICYLATE (SAL) TESTPACKS, ITEM NO. 67694/95
K872330 · DKJ
Toxicology · 22d
Cleared Jul 01, 1987
EASY-TEST AMMONIA (AMON) ITEM NO. 16695
K872110 · JIF
Chemistry · 30d
Cleared May 12, 1987
EASY-TEST EMIT GENTAMICIN (GENT) ITEM NO. 16640
K871329 · LCD
Toxicology · 39d
Cleared May 12, 1987
EASY-TEST CHEM CAL LEVELS 1,2&3/ITEMS 67617 ABC/95
K871638 · JIX
Chemistry · 15d
Cleared Apr 23, 1987
EMDS TIBC PRETREATMENT SET ITEM NO. 67612/93
K871414 · JMO
Chemistry · 15d
Cleared Apr 22, 1987
EMDS GENTAMICIN CALIBRATOR ITEM NO. 67628/95
K871330 · DLJ
Toxicology · 19d
Cleared Mar 19, 1987
EASY-TEST URIC ACID (URIC) #16606
K870868 · KNK
Chemistry · 16d
Cleared Mar 10, 1987
EASY-TEST CREATINE KINASE-MB (CK-MB) #16615
K870462 · CGS
Chemistry · 35d
Cleared Mar 06, 1987
EASY-TEST CALCIUM (CA), ITEM NO. 67528/93
K870170 · CIC
Chemistry · 51d
Cleared Mar 06, 1987
EASY-TEST CREATINE KINASE (CK) NUMBER: 16614
K870461 · CGS
Chemistry · 31d

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