Em Diagnostic Systems, Inc. - FDA 510(k) Cleared Devices
288
Total
288
Cleared
0
Denied
288 devices
Cleared
Feb 05, 1993
LACTATE DEHYDROGENASE (LD) TEST ITEM #65418
Chemistry
141d
Cleared
Feb 05, 1993
ABBOTT QUICKSTART LD-1, MODIFICATION
Chemistry
120d
Cleared
Jan 28, 1993
CHOLESTEROL TEST ITEM# 42374/93, 42322/R1
Chemistry
146d
Cleared
Jan 26, 1993
TRIGLYCERIDES
Chemistry
130d
Cleared
Jan 04, 1993
UREA NITROGEN TEST
Chemistry
94d
Cleared
Dec 28, 1992
ALBUMIN TEST
Chemistry
144d
Cleared
Dec 03, 1992
BICARBONATE
Hematology
76d
Cleared
Nov 25, 1992
EMDS GLUCOSE (GLU-HK) TEST, ITEM 65415
Chemistry
76d
Cleared
Nov 09, 1992
EMDS ALKALINE PHOSPHATASE (ALP) TEST
Chemistry
60d
Cleared
Nov 06, 1992
SYSTEMATE PLUS TRIGLYCERIDE-GLYCEROL BLANKED TEST
Chemistry
57d
Cleared
Oct 26, 1992
CHOLESTEROL TEST
Chemistry
91d
Cleared
Oct 15, 1992
CREATININE-IP TEST, # 42375/93, 42323/R1, 42323/R2
Chemistry
34d
Cleared
Oct 14, 1992
TWO PART INORGANIC PHOSPHORUS TEST
Chemistry
42d
Cleared
Oct 13, 1992
CREATINE KINASE (CK) TEST ITEM #65411
Chemistry
26d
Cleared
Sep 28, 1992
GAMMA GULTAMYL TRANSFERASE TEST
Chemistry
102d
Cleared
Sep 28, 1992
EMDS ALANINE AMINOTRANSFER TEST(ALT) TECH RA 1000
Chemistry
88d
Cleared
Sep 22, 1992
SYSTEMATE PHOSPHORUS TEST TECHNICON RA 1000
Chemistry
56d
Cleared
Sep 22, 1992
SYSTEMATE URICACID TEST, TECHNICON RA 1000
Chemistry
56d
Cleared
Sep 09, 1992
SYSTEMATE DIRECT BILIRUBIN TEST TECHNICON RA 1000
Chemistry
86d
Cleared
Sep 09, 1992
SYSTAMATE ASPARTATE AMINOTRANSFERASE TEST TECHNICO
Chemistry
86d
Cleared
Sep 09, 1992
SYSTEMATE CALCIUM TEST TECHNICON RA 1000
Chemistry
83d
Cleared
Sep 09, 1992
TOTAL BILIRUBIN CATALOG NO. 65407
Chemistry
76d
Cleared
Sep 09, 1992
SYSTEMATE CREATININE TEST
Chemistry
76d
Cleared
Sep 09, 1992
SYSTEMATE TOTAL PROTEIN TEST, TECHNICON RA 1000
Chemistry
69d
Cleared
Sep 09, 1992
AMYLASE TEST
Chemistry
49d
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