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

1,305 results for "abbott"
1009–1032 of 1,305
Search insights Median review: 68d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared May 05, 1986
VISION SGOT (AST) - ADDIT. OF WHOLE BLOOD CLAIM
K860465 · CIT
Abbott Laboratories
Chemistry · 88d
Cleared Apr 21, 1986
VISION SGPT (ALT)
K861002 · CKA
Abbott Laboratories
Chemistry · 34d
Cleared Apr 09, 1986
NUTRIMIX EMPTY CONTAINER
K860042 · KPE
Abbott Laboratories
General Hospital · 93d
Cleared Apr 07, 1986
POLYCATH-H CATHETER
K854308 · FOZ
Abbott Laboratories
General Hospital · 164d
Cleared Apr 03, 1986
A-GENT LIQUID TOTAL PROTEIN
K860426 · CEK
Abbott Laboratories
Chemistry · 58d
Cleared Apr 03, 1986
A-GENT LIQUID CALCIUM
K860425 · CIC
Abbott Laboratories
Chemistry · 58d
Cleared Apr 03, 1986
A-GENT LIQUID TOTAL BILIRUBIN
K860424 · CIG
Abbott Laboratories
Chemistry · 58d
Cleared Mar 17, 1986
A-GENT LIQUID ALBUMIN
K860423 · CJW
Abbott Laboratories
Chemistry · 41d
Cleared Feb 21, 1986
TDX TRANSFERRIN DIAGNOSTIC KIT
K854416 · DDG
Abbott Laboratories
Immunology · 109d
Cleared Feb 06, 1986
EIA PROCESSOR
K854936 · JJE
Abbott Laboratories
Chemistry · 58d
Cleared Jan 24, 1986
TDX C-REACTIVE PROTEIN
K854542 · DCK
Abbott Laboratories
Immunology · 72d
Cleared Jan 17, 1986
TDXR 5-HIAA (URINE)
K854946 · CDA
Abbott Laboratories
Chemistry · 38d
Cleared Jan 14, 1986
VISION SGOT (AST)
K854982 · CIT
Abbott Laboratories
Chemistry · 33d
Cleared Jan 13, 1986
VISION CREATININE
K854846 · CGX
Abbott Laboratories
Chemistry · 40d
Cleared Jan 08, 1986
ABBOTT PHARAMACOKINETICS SYSTEMS
K851573 · NDC
Abbott Laboratories
Chemistry · 266d
Cleared Jan 01, 1986
CELL-DYN 1500 MULTI-PARAMETER HEMATOLOGY ANALYZER
K854368 · GKZ
Abbott Diagnostics
Hematology · 64d
Cleared Dec 05, 1985
ADDITIVE EXTENSION SYRINGE
K853120 · FMF
Abbott Laboratories
General Hospital · 133d
Cleared Dec 05, 1985
ABBOTT STREP A P.S.D.
K852266 · GTZ
Abbott Laboratories
Microbiology · 191d
Cleared Nov 25, 1985
TDX R OPIATES
K854421 · DJG
Abbott Laboratories
Chemistry · 21d
Cleared Nov 25, 1985
TDX CORTISOL
K854419 · JFT
Abbott Laboratories
Chemistry · 21d
Cleared Nov 05, 1985
TDX PHENCYCLIDINE
K854167 · LCM
Abbott Laboratories
Chemistry · 21d
Cleared Nov 05, 1985
TDX COCAINE METABOLITE
K854163 · DIO
Abbott Laboratories
Chemistry · 21d
Cleared Oct 28, 1985
TDX BARBITURATES
K854044 · LGQ
Abbott Laboratories
Toxicology · 26d
Cleared Oct 28, 1985
TDX AMPHETAMINE METHAMPHETAMINE
K853879 · DKZ
Abbott Laboratories
Chemistry · 40d