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
251-275 of 288
Cleared Apr 07, 1986
EASY-TEST URIC ACID (URIC), #67516/93
K860916 · KNK
Chemistry · 27d
Cleared Apr 07, 1986
EASY-TEST TOTAL PROTEIN (TP), #67513/93
K860917 · CEK
Chemistry · 27d
Cleared Apr 03, 1986
EASY-TEST (CHE) REAGENT, ITEM NO. 67522/93
K860641 · DLI
Chemistry · 42d
Cleared Apr 03, 1986
EASY-TEST AMLASE (AMYL), #67521/93
K860918 · JFJ
Chemistry · 23d
Cleared Mar 05, 1986
NEONATAL BILIRUBIN(NBIL) TEST PACK 67661/95
K855079 · CIG
Chemistry · 76d
Cleared Feb 21, 1986
EASY-TEST UREA (BUN) REAGENT
K860135 · CDQ
Chemistry · 38d
Cleared Feb 11, 1986
EMDS GLUCOSE TEST PACK ITEM 67656/95
K855080 · LFR
Chemistry · 54d
Cleared Feb 06, 1986
EASY-TEST ALKALINE PHOSPHATASE (ALP) REAGENT
K860134 · CJE
Chemistry · 23d
Cleared Jan 22, 1986
EMDS TOTAL CK TEST PACK-#67670/95
K855056 · CGS
Chemistry · 35d
Cleared Dec 05, 1985
ULTRAZYME PLUS & SYSTEMATE LDH
K854585 · CFJ
Chemistry · 17d
Cleared Aug 21, 1985
UNI PAK 500 ANALYZER + CHEMISTRY REAGENT ITEM
K852481 · JJQ
Chemistry · 71d
Cleared Jul 15, 1985
MICROSPIN MINICENTRIFUGE ITEM NO. 65204/94
K852482 · JPI
Microbiology · 34d
Cleared Jul 12, 1985
SYSTEMATE CK-MB(NAC-ACTIVATED) ITEM NO. 67205
K852483 · CGS
Chemistry · 31d
Cleared Jun 25, 1985
PREGNANCY CARD TEST
K852066 · JHJ
Chemistry · 46d
Cleared Feb 01, 1985
SYSTE MATE TIBC HEM NO. 67225
K850128 · JMO
Chemistry · 18d
Cleared Jan 28, 1985
SYSTE MATE IRON, HEM NO. 67224
K845020 · JIY
Chemistry · 32d
Cleared Sep 28, 1984
SYSTEMATE A AMYLASE HEM 67204
K843645 · CIJ
Chemistry · 11d
Cleared Sep 20, 1984
SYSTEMATE T-BILI 67212
K843328 · CIG
Chemistry · 24d
Cleared Sep 20, 1984
SYSTEMATE D-BILI 67213
K843329 · CIG
Chemistry · 24d
Cleared Sep 20, 1984
SYSTEMATE GOT 67208
K843333 · CIT
Chemistry · 24d
Cleared Sep 20, 1984
SYSTEMATE GPT 67209
K843334 · CKA
Chemistry · 24d
Cleared Sep 14, 1984
SYSTEMATE BUN HEM NO. 67221
K843326 · CDQ
Chemistry · 18d
Cleared Sep 14, 1984
SYSTEMATE CHOLESTEROL 67222
K843327 · CHH
Chemistry · 18d
Cleared Sep 14, 1984
SYSTEMATE PHOSPHORUS 67217
K843330 · CEO
Chemistry · 18d
Cleared Sep 13, 1984
SYSTEMATE 2GT - 67207
K843268 · JQB
Chemistry · 24d

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