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

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1,305 results for "abbott"
553–576 of 1,305
Search insights Median review: 68d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared May 18, 1998
CA
K981232 · CJY
Abbott Mfg., Inc.
Chemistry · 45d
Cleared May 12, 1998
CO2
K981231 · KHS
Abbott Mfg., Inc.
Chemistry · 39d
Cleared May 07, 1998
URIC ACID
K981189 · CDO
Abbott Laboratories
Chemistry · 35d
Cleared May 07, 1998
GLU
K981185 · CFR
Abbott Laboratories
Chemistry · 35d
Cleared May 01, 1998
TBIL
K981336 · CIG
Abbott Laboratories
Chemistry · 18d
Cleared May 01, 1998
IRON
K981241 · JIY
Abbott Laboratories
Chemistry · 25d
Cleared May 01, 1998
CREATINE KINASE (CK)
K981218 · CGS
Abbott Laboratories
Chemistry · 28d
Cleared May 01, 1998
MG
K981192 · JGJ
Abbott Laboratories
Chemistry · 29d
Cleared Apr 29, 1998
ABBOTT AXSYM 3RD GENERATION TSH ASSAY
K981060 · JLW
Abbott Laboratories
Chemistry · 37d
Cleared Apr 24, 1998
DIRECT BILIRUBIN (DBIL)
K981222 · CIG
Abbott Laboratories
Chemistry · 21d
Cleared Apr 24, 1998
ABBOTT CELL-DYN 3000 SERIES HEMATOLOGY SYSTEMS
K980614 · GKZ
Abbott Laboratories
Hematology · 81d
Cleared Apr 23, 1998
ASPARTATE AMINOTRANSFERASE (AST)
K981225 · CIT
Abbott Laboratories
Chemistry · 20d
Cleared Apr 23, 1998
ASPARTATE AMINOTRANSFERASE ACTIVATED ( AST ACTIVATED)
K981221 · CIT
Abbott Laboratories
Chemistry · 20d
Cleared Apr 01, 1998
AEROSET SYSTEM
K980367 · CGZ
Abbott Laboratories
Chemistry · 62d
Cleared Mar 17, 1998
ABBOTT GEMSTAR IV INFUSION PUMP
K974778 · FRN
Abbott Laboratories
General Hospital · 85d
Cleared Mar 03, 1998
ABBOTT TESTPACK PLUS STREP A WITH ON BOARD CONTROLS (OBC) II
K971522 · GTZ
Abbott Laboratories
Microbiology · 312d
Cleared Feb 13, 1998
ABBOTT ALCYON(TM) 300 (WITHOUT ISE MODULE) AND 300I (WITH ISE MODULE) ANALYZER
K974779 · JJE
Abbott Laboratories
Chemistry · 53d
Cleared Feb 12, 1998
ABBOTT AXSYM SYSTEM
K974651 · JJE
Abbott Laboratories
Chemistry · 66d
Cleared Nov 25, 1997
ABBOTT AXSYM TROPONIN-I
K974103 · MMI
Abbott Laboratories
Chemistry · 25d
Cleared Nov 10, 1997
IMX CA 15-3
K964407 · MOI
Abbott Laboratories
Immunology · 371d
Cleared Nov 07, 1997
FLEXIFLO LOW-PROFILE BALLOON GASTROSTOMY TUBE
K962554 · KNT
Abbott Laboratories
Gastroenterology & Urology · 494d
Cleared Nov 04, 1997
IMX CA 125
K964185 · LTK
Abbott Diagnostics
Immunology · 379d
Cleared Nov 04, 1997
AXSYM CA 125
K964020 · LTK
Abbott Laboratories
Immunology · 393d
Cleared Sep 16, 1997
ABBOTT CELL-DYN 3200 SYSTEM
K972354 · GKZ
Abbott Laboratories
Hematology · 84d