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

901 results for "Abbott Laboratories"
169–192 of 901
Search insights Median review: 61d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Feb 16, 1999
CK
K983070 · CGS
Abbott Laboratories
Chemistry · 167d
Cleared Feb 05, 1999
ABBOTT ARCHITECT FOLATE
K984301 · CGN
Abbott Laboratories
Chemistry · 65d
Cleared Feb 03, 1999
ABBOTT ARCHITECT B12
K984108 · LIG
Abbott Laboratories
Chemistry · 78d
Cleared Jan 29, 1999
APOLIPOPROTEIN A1
K983289 · DER
Abbott Laboratories
Immunology · 133d
Cleared Jan 28, 1999
UALB
K983774 · JIR
Abbott Laboratories
Chemistry · 94d
Cleared Jan 26, 1999
APOB
K983281 · DFC
Abbott Laboratories
Immunology · 130d
Cleared Jan 12, 1999
ABBOTT PLUM A+ INFUSION PUMP
K982159 · FRN
Abbott Laboratories
General Hospital · 207d
Cleared Dec 07, 1998
ABBOTT ARCHITECT FERRITIN
K983759 · DBF
Abbott Laboratories
Immunology · 42d
Cleared Dec 01, 1998
ABBOTT ARCHEITECT TOTAL B-HCG
K983424 · DHA
Abbott Laboratories
Chemistry · 63d
Cleared Nov 25, 1998
ABBOTT ARCHITECT TOTAL T4
K983440 · KLI
Abbott Laboratories
Chemistry · 57d
Cleared Nov 20, 1998
ABBOTT LIFECARE STANDARD TUBING INFUSION PUMP
K983838 · FRN
Abbott Laboratories
General Hospital · 30d
Cleared Nov 20, 1998
ABBOTT ARCHITECT TSH
K983442 · JLW
Abbott Laboratories
Chemistry · 51d
Cleared Nov 20, 1998
ABBOTT ARCHITECT FREE T3
K983439 · CDP
Abbott Laboratories
Chemistry · 52d
Cleared Nov 20, 1998
ABBOTT ARCHITECT TOTAL T3
K983434 · CDP
Abbott Laboratories
Chemistry · 52d
Cleared Nov 20, 1998
ABBOTT ARCHITECT FREE T4
K983417 · CEC
Abbott Laboratories
Chemistry · 52d
Cleared Nov 18, 1998
ABBOTT ARCHITECT TESTOSTERONE
K983212 · CDZ
Abbott Laboratories
Chemistry · 65d
Cleared Nov 18, 1998
ABBOTT TESTPACK PLUS H. PYLORI
K982362 · LYR
Abbott Laboratories
Microbiology · 135d
Cleared Nov 16, 1998
ABBOTT AXSYM MYOGLOBIN
K983848 · DDR
Abbott Laboratories
Chemistry · 17d
Cleared Nov 04, 1998
C3
K983441 · CZW
Abbott Laboratories
Immunology · 35d
Cleared Nov 04, 1998
IGA
K983359 · CZP
Abbott Laboratories
Immunology · 41d
Cleared Nov 04, 1998
C4
K983356 · DBI
Abbott Laboratories
Immunology · 41d
Cleared Nov 04, 1998
IGG
K983221 · DEW
Abbott Laboratories
Immunology · 51d
Cleared Nov 04, 1998
TRF
K983167 · DDG
Abbott Laboratories
Immunology · 55d
Cleared Nov 04, 1998
IGM
K983132 · DFT
Abbott Laboratories
Immunology · 57d