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."
49–72 of 288
Search insights Median review: 43d Cleared: 100% Top manufacturer: Em Diagnostic Systems, Inc. Lead specialty: Chemistry
Cleared Sep 09, 1992
SYSTAMATE ASPARTATE AMINOTRANSFERASE TEST TECHNICO
K922857 · CIT
Em Diagnostic Systems, Inc.
Chemistry · 86d
Cleared Sep 09, 1992
SYSTEMATE DIRECT BILIRUBIN TEST TECHNICON RA 1000
K922856 · CIG
Em Diagnostic Systems, Inc.
Chemistry · 86d
Cleared Mar 02, 1992
ABBOTT QUICKSTART AMYLASE, #5AXX
K920583 · JFJ
Em Diagnostic Systems, Inc.
Chemistry · 21d
Cleared Jan 15, 1992
ABBOTT QUICKSTART TIGLYCERIDES REAGENT
K915732 · CDT
Em Diagnostic Systems, Inc.
Chemistry · 26d
Cleared Jan 03, 1992
ABBOTT QUICKSTART SGOT, ITEM NUMBER: 5A42
K914463 · CIT
Em Diagnostic Systems, Inc.
Chemistry · 88d
Cleared Dec 31, 1991
QUICKSTART UREA NITROGEN
K914903 · CDN
Em Diagnostic Systems, Inc.
Chemistry · 60d
Cleared Dec 18, 1991
ABBOTT QUICKSTART CHOLESTEROL TEST
K913565 · CHH
Em Diagnostic Systems, Inc.
Chemistry · 131d
Cleared Dec 13, 1991
CREATINE KINASE MB TEST ITEM NUMBER 5A46
K914361 · CGS
Em Diagnostic Systems, Inc.
Chemistry · 73d
Cleared Nov 22, 1991
ABBOTT QUICKSTART SGPT, ITEM NUMBER 5A43
K914464 · CKA
Em Diagnostic Systems, Inc.
Chemistry · 46d
Cleared Nov 22, 1991
ABBOTT QUICKSTART TRIGLYCERIDES REAGENTS, #5A33
K914018 · CDT
Em Diagnostic Systems, Inc.
Chemistry · 74d
Cleared Nov 22, 1991
ABBOTT QUICKSTART ALKA PHOSPHATASE (ALP) ITEM#5A38
K913921 · CJE
Em Diagnostic Systems, Inc.
Chemistry · 80d
Cleared Nov 05, 1991
ABBOTT QUICKSTART MAGNESIUM TEST, ITEM #5A32
K913764 · JGJ
Em Diagnostic Systems, Inc.
Chemistry · 75d
Cleared Oct 31, 1991
ABBOTT QUICK START CREATINE KINASE(CK) ITEM #5A17
K912807 · JFY
Em Diagnostic Systems, Inc.
Chemistry · 128d
Cleared Oct 25, 1991
ABBOTT QUICKSTART DIRECT BILIRUBIN (DBIL) #5A20
K913466 · CIG
Em Diagnostic Systems, Inc.
Chemistry · 81d
Cleared Oct 21, 1991
ABBOTT QUICKSTART LD-1,#5A30
K914261 · JGF
Em Diagnostic Systems, Inc.
Chemistry · 28d
Cleared Oct 11, 1991
ABBOTT QUICKSTART LDH,#5A31
K914262 · CFJ
Em Diagnostic Systems, Inc.
Chemistry · 18d
Cleared Oct 11, 1991
ABBOTT QUICKSTART TOTAL BILIRUBIN (TBIL) #5A21
K913307 · CIG
Em Diagnostic Systems, Inc.
Chemistry · 78d
Cleared Oct 09, 1991
ABBOTT QLUICKSTART IRON TEST, ITEM #5A29
K913705 · CFM
Em Diagnostic Systems, Inc.
Chemistry · 51d
Cleared Oct 09, 1991
ABBOTT QUICKSTART ALBUMIN BCP (ALBP)#5A16
K913025 · CJW
Em Diagnostic Systems, Inc.
Chemistry · 92d
Cleared Oct 02, 1991
ABBOTT QUICKSTART ASPARATE AMINOTRANSFERASE TEST
K914068 · CIT
Em Diagnostic Systems, Inc.
Chemistry · 21d
Cleared Sep 27, 1991
ABBOTT QUICKSTART ALBUMIN TEST (ALBG) ITEM #5A37
K913920 · CIX
Em Diagnostic Systems, Inc.
Chemistry · 24d
Cleared Sep 27, 1991
ABBOTT QUICKSTART URIC ACID TEST (URCA) ITEM# 5A34
K913706 · KNK
Em Diagnostic Systems, Inc.
Chemistry · 39d
Cleared Sep 19, 1991
ABBOTT QUICKSTART TIBC PRETREATMENT KIT, 5A29-01
K913922 · JMO
Em Diagnostic Systems, Inc.
Chemistry · 16d
Cleared Sep 19, 1991
ABBOTT QUICKSTART ALANINE AMINOTRANSFER
K913846 · CKA
Em Diagnostic Systems, Inc.
Chemistry · 22d