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
259 devices
176-200 of 259
Cleared Jul 27, 1987
EMDS GAMMA-GLUTAMYL TRANSFERASE (GGT) 67680/95
K872322 · JQB
Chemistry · 40d
Cleared Jul 01, 1987
EASY-TEST AMMONIA (AMON) ITEM NO. 16695
K872110 · JIF
Chemistry · 30d
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 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
Cleared Mar 06, 1987
EASY-TEST MAGNESIUM (MG) ITEM NO. 16XXX
K870553 · JGJ
Chemistry · 24d
Cleared Mar 04, 1987
EASY-TEST CHOLESTEROL(CHOL) NUMBER 16607
K870407 · CHH
Chemistry · 29d
Cleared Mar 04, 1987
EASY-TEST TRIGLYCERIDE (TRIG) NUMBER 16608
K870408 · CDT
Chemistry · 29d
Cleared Mar 04, 1987
EMDS UREA NITROGEN (BUN) TESTPACKS ITEM #67654/95
K870571 · CDQ
Chemistry · 22d
Cleared Feb 20, 1987
IRON(IRN) TESTPACK, ITEM NO. 67659/95
K870144 · JIY
Chemistry · 38d
Cleared Feb 11, 1987
AMMONIA (AMON) TESTPACK, ITEM NO. 67689/95
K870143 · JIF
Chemistry · 29d
Cleared Feb 11, 1987
EMIT QUINIDINE CALIBRATOR ITEM NO. 67631/93
K870247 · DLJ
Chemistry · 21d
Cleared Dec 31, 1986
EASY-TEST ALBUMIN (ALB), ITEM NO. 67529/93
K864715 · CIX
Chemistry · 28d
Cleared Nov 28, 1986
EMDS(TM) ALANINE AMINOTRANSFERASE (ALT) #67658/95
K863962 · CKA
Chemistry · 49d
Cleared Nov 28, 1986
EMDS(TM) ASPARTATE AMINOTRANSFERASE (AST) 67657/95
K863963 · CIT
Chemistry · 49d
Cleared Nov 05, 1986
EMDS(TM) CREATININE(CREA) TESTPACKS, #67669/95
K863738 · CGX
Chemistry · 43d
Cleared Oct 29, 1986
CEREBROSPINAL FLUID PROTEIN TESTPACK, #67668/95
K863478 · JGQ
Chemistry · 50d
Cleared Oct 29, 1986
EMDS URIC ACID (URC A) TESTPACK, ITEM #67664/95
K863660 · CDO
Chemistry · 41d
Cleared Oct 29, 1986
EMDS(TM) PHOSPHORUS (PHOS) TESTPACKS, #67678/95
K863718 · CEO
Chemistry · 36d
Cleared Sep 29, 1986
EASY-TEST CARBON DIOXIDE (CO2) ITEM #67649/95
K863544 · KHS
Chemistry · 17d
Cleared Sep 26, 1986
EMDS(TM) LACTIC DEHYDROGENASE TESTPACKS, #67660/95
K863477 · CFJ
Chemistry · 17d
Cleared Sep 25, 1986
EASY-TEST LACTIC DEHYDROGENASE (LDH) # 67527/95
K863545 · CFJ
Chemistry · 13d

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