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"
985–1008 of 1,305
Search insights Median review: 68d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Jan 05, 1987
ABBOTT SPECTRUM GLUCOSE REAGENT
K864224 · CGA
Abbott Laboratories
Chemistry · 69d
Cleared Dec 16, 1986
VISION(TM) AMYLASE
K864435 · JFJ
Abbott Laboratories
Chemistry · 34d
Cleared Dec 16, 1986
TDX(R) II ANALYZER
K864319 · JJQ
Abbott Laboratories
Chemistry · 43d
Cleared Dec 12, 1986
ABBOTT LIFECARE(R) 4100 PCA INFUSER
K863997 · FRN
Abbott Laboratories
General Hospital · 59d
Cleared Nov 24, 1986
VISION (TM) GGTP
K864208 · JPZ
Abbott Laboratories
Chemistry · 28d
Cleared Nov 13, 1986
A-GENT(TM) LIQUID GLUCOSE TRINDER
K863948 · CGA
Abbott Laboratories
Chemistry · 34d
Cleared Nov 13, 1986
VISION (TM) CALCIUM
K863670 · CIC
Abbott Laboratories
Chemistry · 56d
Cleared Nov 12, 1986
ABBOTT B2-MICROGLOBULIN RIA
K864130 · JZG
Abbott Laboratories
Immunology · 22d
Cleared Oct 03, 1986
TDX(R) AMYLASE II
K863622 · JFJ
Abbott Laboratories
Chemistry · 17d
Cleared Sep 29, 1986
PROLACTIN RIABEAD II DIAGNOSTIC KIT
K863240 · CFT
Abbott Laboratories
Chemistry · 38d
Cleared Sep 25, 1986
ABBOTT SPECTRUM PHOSPHORUS REAGENT
K863088 · CEO
Abbott Laboratories
Chemistry · 43d
Cleared Sep 16, 1986
ABBOTT TESTPACK (TM) ACUTE HEP A CONTROL KIT
K863099 · JJK
Abbott Laboratories
Microbiology · 34d
Cleared Sep 16, 1986
ABBOTT RSV EIA
K862429 · GQG
Abbott Laboratories
Microbiology · 82d
Cleared Sep 15, 1986
TESTPACK ACUTE HCG URINGE CONTROLS
K863127 · JJW
Abbott Laboratories
Chemistry · 31d
Cleared Sep 15, 1986
TESTPACK ACUTE HCG SERUM CONTROLS
K863126 · JJX
Abbott Laboratories
Chemistry · 31d
Cleared Sep 15, 1986
ABBOTT TESTPACK (TM) HCG SERUM
K863032 · JHI
Abbott Laboratories
Chemistry · 35d
Cleared Aug 27, 1986
TDX IMMUNOGLOBULIN A DIAGNOSTIC KIT
K855046 · CZP
Abbott Laboratories
Immunology · 253d
Cleared Aug 27, 1986
TDX IMMUNOGLOBULIN M DIAGNOSTIC KIT
K854944 · DAH
Abbott Laboratories
Immunology · 260d
Cleared Aug 18, 1986
VISION(TM) HEMOGLOBIN
K862202 · KHG
Abbott Laboratories
Hematology · 69d
Cleared Jul 11, 1986
TDX BENZODIAZEPINES
K862250 · JXM
Abbott Laboratories
Toxicology · 29d
Cleared Jul 07, 1986
TDX REA LACTIC ACID
K861741 · KHP
Abbott Laboratories
Chemistry · 62d
Cleared Jun 17, 1986
VISION ALBUMIN
K862138 · CJW
Abbott Laboratories
Chemistry · 13d
Cleared Jun 17, 1986
VISION TOTAL PROTEIN
K861798 · CEK
Abbott Laboratories
Chemistry · 39d
Cleared Jun 17, 1986
VISION THEOPHYLLINE - ADDIT. OF WHOLE BLOOD CLAIM
K860464 · KLS
Abbott Laboratories
Toxicology · 131d