FDA 510(k) Regulatory Intelligence Search

Search devices, predicates, manufacturers and submission history used by regulatory affairs and medical device strategy teams.

174,883 clearances · 1976 to present · Updated monthly from FDA records

288 results for "Em Diagnostic Systems, Inc."
73–96 of 288
Search insights Median review: 43d Cleared: 100% Top manufacturer: Em Diagnostic Systems, Inc. Lead specialty: Chemistry
Cleared Sep 18, 1991
ABBOTT QUICKSTART CREATININE TEST(CREA) ITEM# 5A28
K913707 · CGX
Em Diagnostic Systems, Inc.
Chemistry · 30d
Cleared Sep 11, 1991
ABBOTT QUICKSTART BICARBONATE TEST CO2 ITEM# 5A22
K912806 · KHS
Em Diagnostic Systems, Inc.
Chemistry · 78d
Cleared Aug 12, 1991
ABBOTT QUICKSTART PHOSPHORUS(PHOS) ITEM #5A14
K912809 · CEO
Em Diagnostic Systems, Inc.
Chemistry · 48d
Cleared Jul 30, 1991
ABBOTT QUICKSTART TOTAL PROTEIN TEST ITEM# 5A13
K912810 · CEK
Em Diagnostic Systems, Inc.
Chemistry · 35d
Cleared Jul 30, 1991
ABBOTT QUICK START GLUCOSE (GLUE) ITEM# 5A15
K912808 · CFR
Em Diagnostic Systems, Inc.
Chemistry · 35d
Cleared Jul 26, 1991
ABBOTT QUICKSTART GAMMA-GLUTAMYTRANSFERASE TEST
K913024 · JQB
Em Diagnostic Systems, Inc.
Chemistry · 17d
Cleared May 08, 1991
SYSTEMATE CREATININE (EPOS APPLICATION) #65413
K905658 · CGX
Em Diagnostic Systems, Inc.
Chemistry · 141d
Cleared Apr 12, 1991
SYSTEMATE LACTATE DEHYDROGENASE (EPOS APPL) #65476
K910640 · CFJ
Em Diagnostic Systems, Inc.
Chemistry · 58d
Cleared Apr 12, 1991
SYSTEMATE ALKALINE PHOSPHATASE(EPOS APPL) #65483
K910639 · CJE
Em Diagnostic Systems, Inc.
Chemistry · 58d
Cleared Mar 11, 1991
SYSTEMATE TRIGLYCERIIDES (EPOS APPLICATION) #65477
K910638 · CDT
Em Diagnostic Systems, Inc.
Chemistry · 26d
Cleared Feb 13, 1991
OLYMPUS URINE PH CALIBRATORS LEVELS I AND II
K905477 · JIS
Em Diagnostic Systems, Inc.
Chemistry · 69d
Cleared Jan 31, 1991
SYSTEMATE TOTAL PROTEIN (EPOS APPLICATION) #65420
K905661 · CEK
Em Diagnostic Systems, Inc.
Chemistry · 44d
Cleared Jan 25, 1991
SYSTEMATE ALBUMIN (EPOS APPLICATION) #65401
K905660 · CIX
Em Diagnostic Systems, Inc.
Chemistry · 38d
Cleared Jan 15, 1991
SYSTEMATE CALCIUM (EPOS APPLICATION) #65409
K905659 · CIC
Em Diagnostic Systems, Inc.
Chemistry · 29d
Cleared Jan 04, 1991
SYSTEMATE GGT (EPOS APPLICATION) #65414
K905662 · JQB
Em Diagnostic Systems, Inc.
Chemistry · 17d
Cleared Oct 04, 1990
SYSTEMATE BICARBONATE OLYMPUS BICARBONATE
K903409 · KHS
Em Diagnostic Systems, Inc.
Chemistry · 65d
Cleared Sep 12, 1990
OLYMPUS INORGANIC PHOSPHORUS
K903696 · CEO
Em Diagnostic Systems, Inc.
Chemistry · 28d
Cleared Sep 12, 1990
ALANINE AMINOTRANSFERASE TEST
K903198 · CKA
Em Diagnostic Systems, Inc.
Chemistry · 55d
Cleared Sep 07, 1990
UREA NITROGEN TEST
K903334 · CDQ
Em Diagnostic Systems, Inc.
Chemistry · 44d
Cleared Aug 17, 1990
SYSTEMATE URIC ACID (URCA) ITEM NUMBER 65422
K903335 · CDO
Em Diagnostic Systems, Inc.
Chemistry · 23d
Cleared Aug 17, 1990
CREATINE KINASE TEST (CK) ITEM NUMBER 65411
K903333 · CGS
Em Diagnostic Systems, Inc.
Chemistry · 23d
Cleared Aug 17, 1990
SYSTEMATE AMYLASE (AMYL) ITEM NUMBER 65404
K903332 · JFJ
Em Diagnostic Systems, Inc.
Chemistry · 23d
Cleared Aug 17, 1990
ASPARTATE AMINOTRANSFERASE TEST
K903197 · CIT
Em Diagnostic Systems, Inc.
Chemistry · 29d
Cleared Jul 10, 1990
CREATINE KINASE-MB TEST (MB-DS) ITEM #67655
K902483 · CGS
Em Diagnostic Systems, Inc.
Chemistry · 35d