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
151-175 of 288
Cleared Dec 14, 1988
ASPARTATE AMINOTRANSFERASE TEST ITEM NO. 65654
K884377 · CIT
Chemistry · 57d
Cleared Nov 10, 1988
EMDS GLUCOSE (GLUC) TESTPACKS, NO. 67697/95
K884021 · CFR
Chemistry · 49d
Cleared Nov 10, 1988
LACTATE DEHYDROGENASE TEST (LD) ITEM NO. 65668
K884548 · CFJ
Chemistry · 10d
Cleared Nov 10, 1988
ALKALINE PHOSPHATASE TEST (ALP) ITEM NO. 65651
K884549 · CJE
Chemistry · 10d
Cleared Aug 23, 1988
EMDS ACETAMINOPHEN CALIBRATOR NO. 67636/95
K882766 · DLG
Toxicology · 48d
Cleared Aug 08, 1988
EASY-TEST EMIT ACETAMINOPHEN (ACTM) NO. 16653
K882719 · LDP
Toxicology · 38d
Cleared Jun 01, 1988
EASY-TEST EMIT(R) ETHOSUXIMIDE (ETHS) ITEM 16647
K881607 · DLF
Toxicology · 50d
Cleared May 27, 1988
AUTO TROL(TM) CONTROL, LEVELS 1 & 2 #16692 & 16693
K881229 · JJY
Chemistry · 66d
Cleared May 27, 1988
EMDS LIDOCAINE CALIBRATOR ITEM NO. 67XXX/95
K881337 · DLJ
Toxicology · 59d
Cleared Mar 11, 1988
ADDITIONAL ALLERGENS FOR IGE FAST-PLUS TEST
K880003 · DHB
Immunology · 67d
Cleared Feb 25, 1988
EASY-TEST POTASSIUM K ITEM NUMBER 19XXX
K880339 · CEJ
Chemistry · 30d
Cleared Feb 11, 1988
EASY-TEST PROTHROMBIN TIME PT ITEM NO. 16628
K875062 · GJS
Hematology · 64d
Cleared Jan 21, 1988
EASY-TEST ALANINE AMINOTRANSFERASE (ALAT) #19017
K874586 · CKA
Chemistry · 73d
Cleared Jan 21, 1988
EASY-TEST ASPARTATE AMINOTRANSFERASE (ASAT) #19010
K874600 · CIT
Chemistry · 73d
Cleared Dec 22, 1987
EASY-TEST AMYLASE (AMYL), ITEM NUMBER 19019
K874705 · JEJ
Chemistry · 33d
Cleared Dec 18, 1987
EASY-TEST GLUCOSE (GLUC), ITEM NUMBER 19008
K874708 · LFR
Chemistry · 29d
Cleared Nov 25, 1987
EASY-TEST TOTAL PROTEIN (TP) ITEM NUMBER: 19011
K874476 · CEK
Chemistry · 23d
Cleared Nov 24, 1987
EASY-TEST HDL CHOLESTEROL ITEM NUMBER 16683
K874397 · LBS
Chemistry · 27d
Cleared Nov 23, 1987
EASY-TEST UREA NITROGEN (BUN) ITEM NUMBER: 19010
K874477 · CDQ
Chemistry · 21d
Cleared Nov 09, 1987
EMDS N-ACETYLPROCAINAMIDE CALIBRATOR #67635/95
K874101 · DLJ
Toxicology · 32d
Cleared Nov 06, 1987
EASY-TEST CREATININE (CREA) ITEM NO. 19009
K874088 · CGX
Chemistry · 30d
Cleared Nov 05, 1987
EMDS PROCAINAMIDE CALIBRATOR ITEM NO. 67634/95
K874102 · DLJ
Toxicology · 28d
Cleared Nov 04, 1987
EASY-TEST PHOSPHORUS (PHOS) ITEM NO. 16687
K874153 · CEO
Chemistry · 22d
Cleared Oct 29, 1987
EASY-TEST SALICYLATE (SAL) #16691
K873425 · DKJ
Chemistry · 65d
Cleared Oct 29, 1987
EASY-TEST EMIT(R) AMIKACIN (AMIK) NO. 16645
K873426 · KLP
Toxicology · 65d

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