FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

1,299 results for "abbott"
745–768 of 1,299
Search insights Median review: 68d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Jan 03, 1992
ABBOTT QUICKSTART SGOT, ITEM NUMBER: 5A42
K914463 · CIT
Em Diagnostic Systems, Inc.
Chemistry · 88d
Cleared Dec 19, 1991
PROVIDER APM INFUSION PUMP
K914349 · FRN
Abbott Laboratories
General Hospital · 83d
Cleared Dec 18, 1991
ABBOTT QUICKSTART CHOLESTEROL TEST
K913565 · CHH
Em Diagnostic Systems, Inc.
Chemistry · 131d
Cleared Dec 13, 1991
LIFESHIELD EXTENSION SET
K912103 · FPK
Abbott Laboratories
General Hospital · 214d
Cleared Nov 29, 1991
ABBOTT MATRIX AERO PLUS SYSTEM
K913150 · DHB
Abbott Laboratories
Immunology · 136d
Cleared Nov 29, 1991
ABBOTT IMX TOXO IGM POSITIVE CONTROL
K913106 · LGD
Abbott Laboratories
Microbiology · 140d
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
FLEXIFLO OVER-THE-GUIDEWIRE GAST KIT W/CR-BAR BUMP
K913786 · KNT
Abbott Laboratories
Gastroenterology & Urology · 74d
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 30, 1991
PANCRETEC PROVIDER ONE INFUSION SYSTEM, MODIFIED
K913720 · FRN
Abbott Laboratories
General Hospital · 90d
Cleared Oct 30, 1991
PANCRETEC I.V. MODEL 5500 INFUSER
K913719 · FRN
Abbott Laboratories
General Hospital · 90d
Cleared Oct 30, 1991
PANCRETEC I.V. MODEL 5000 INFUS DEVICE, MODIFIED
K913718 · FRN
Abbott Laboratories
General Hospital · 90d
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