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."
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