Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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