Em Diagnostic Systems, Inc. - FDA 510(k) Cleared Devices
288
Total
288
Cleared
0
Denied
288 devices
Cleared
Apr 07, 1986
EASY-TEST URIC ACID (URIC), #67516/93
Chemistry
27d
Cleared
Apr 07, 1986
EASY-TEST TOTAL PROTEIN (TP), #67513/93
Chemistry
27d
Cleared
Apr 03, 1986
EASY-TEST (CHE) REAGENT, ITEM NO. 67522/93
Chemistry
42d
Cleared
Apr 03, 1986
EASY-TEST AMLASE (AMYL), #67521/93
Chemistry
23d
Cleared
Mar 05, 1986
NEONATAL BILIRUBIN(NBIL) TEST PACK 67661/95
Chemistry
76d
Cleared
Feb 21, 1986
EASY-TEST UREA (BUN) REAGENT
Chemistry
38d
Cleared
Feb 11, 1986
EMDS GLUCOSE TEST PACK ITEM 67656/95
Chemistry
54d
Cleared
Feb 06, 1986
EASY-TEST ALKALINE PHOSPHATASE (ALP) REAGENT
Chemistry
23d
Cleared
Jan 22, 1986
EMDS TOTAL CK TEST PACK-#67670/95
Chemistry
35d
Cleared
Dec 05, 1985
ULTRAZYME PLUS & SYSTEMATE LDH
Chemistry
17d
Cleared
Aug 21, 1985
UNI PAK 500 ANALYZER + CHEMISTRY REAGENT ITEM
Chemistry
71d
Cleared
Jul 15, 1985
MICROSPIN MINICENTRIFUGE ITEM NO. 65204/94
Microbiology
34d
Cleared
Jul 12, 1985
SYSTEMATE CK-MB(NAC-ACTIVATED) ITEM NO. 67205
Chemistry
31d
Cleared
Jun 25, 1985
PREGNANCY CARD TEST
Chemistry
46d
Cleared
Feb 01, 1985
SYSTE MATE TIBC HEM NO. 67225
Chemistry
18d
Cleared
Jan 28, 1985
SYSTE MATE IRON, HEM NO. 67224
Chemistry
32d
Cleared
Sep 28, 1984
SYSTEMATE A AMYLASE HEM 67204
Chemistry
11d
Cleared
Sep 20, 1984
SYSTEMATE T-BILI 67212
Chemistry
24d
Cleared
Sep 20, 1984
SYSTEMATE D-BILI 67213
Chemistry
24d
Cleared
Sep 20, 1984
SYSTEMATE GOT 67208
Chemistry
24d
Cleared
Sep 20, 1984
SYSTEMATE GPT 67209
Chemistry
24d
Cleared
Sep 14, 1984
SYSTEMATE BUN HEM NO. 67221
Chemistry
18d
Cleared
Sep 14, 1984
SYSTEMATE CHOLESTEROL 67222
Chemistry
18d
Cleared
Sep 14, 1984
SYSTEMATE PHOSPHORUS 67217
Chemistry
18d
Cleared
Sep 13, 1984
SYSTEMATE 2GT - 67207
Chemistry
24d
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