FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,730 clearances · 1976 to present · Updated monthly from FDA records

1,301 results for "abbott"
985–1008 of 1,301
Search insights Median review: 68d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
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
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