FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,218 clearances · 1976 to present · Updated monthly from FDA records

Filters: Chemistry ×
13,224 results
10609–10632 of 13,224
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Mar 10, 1983
DIGIFLEX AUTOMATIC PIPETTE
K830157 · JQW
Micromedic Systems
Chemistry · 51d
Cleared Mar 10, 1983
AUTOMATED ELISA READER LBI 300
K830227 · JTQ
Bionetic Laboratory Products
Chemistry · 45d
Cleared Mar 10, 1983
SALT BRIDGE SOLUTION & URINE DILUENT
K830341 · JIX
Shaban Mfg. Co.
Chemistry · 36d
Cleared Mar 10, 1983
KINETI COUNT 48 IMMUNOASSAY SYSTEM
K830365 · JJJ
Medical & Scientific Designs, Inc.
Chemistry · 34d
Cleared Mar 10, 1983
TDX METHOTREXATE
K830398 · LAO
Abbott Laboratories
Chemistry · 31d
Cleared Mar 10, 1983
LBI-100 37DEGREES INCUBATOR
K830405 · JTQ
Bionetic Laboratory Products
Chemistry · 31d
Cleared Mar 09, 1983
HANDI-WASH
K823787 · LIB
Dynatech Corp.
Chemistry · 83d
Cleared Mar 08, 1983
MICRO STIX #011-010-5000 & HOLDER#5100
K823833 · LIB
Dynatech Corp.
Chemistry · 77d
Cleared Mar 07, 1983
PARAGON IMMUNOELECTROPHORESIS REAGENT
K823884 · CFF
Beckman Instruments, Inc.
Chemistry · 70d
Cleared Mar 07, 1983
MINIATURE ION SELECTIVE ELECTRODES
K830130 · JSG
Ionetics, Inc.
Chemistry · 55d
Cleared Mar 07, 1983
FECAL OCCULT SLIDE TEST KIT
K830223 · KHE
Cambridge Chemical Products, Inc.
Chemistry · 42d
Cleared Mar 07, 1983
PARAMAX ANALYTICAL SYS
K830318 · JJE
American Dade
Chemistry · 35d
Cleared Mar 01, 1983
MR 600 MICROPLATE READER
K823512 · JJQ
Laboratory and Medical Products Group
Chemistry · 92d
Cleared Mar 01, 1983
ABBOTT LABORATORIES STREP A EIA
K823569 · GTZ
Abbott Laboratories
Chemistry · 88d
Cleared Feb 28, 1983
MANUALISA MICROTITRATION PLATE READER
K823590 · JJQ
Ortho Diagnostic Systems, Inc.
Chemistry · 84d
Cleared Feb 28, 1983
IL VIDEO 22,21 & II ATOMIC SPECTROPHOTO-
K830149 · DWD
Instrumentation Laboratory CO
Chemistry · 42d
Cleared Feb 28, 1983
REFEREE BLOOD GAS ANALYZER CONTROLS
K830181 · JJS
Analytical Products, Inc.
Chemistry · 41d
Cleared Feb 28, 1983
LITHIUM DILUENT
K830283 · JIS
Shaban Mfg. Co.
Chemistry · 33d
Cleared Feb 28, 1983
ULTRA ZYME PLUS GAMMA GT #65055 & 56
K830308 · JQB
Emd Chemicals, Inc.
Chemistry · 28d
Cleared Feb 28, 1983
ULTRA CHEM ENZYMATIC CHOLESTEROL OXIDASE
K830309 · CHH
Emd Chemicals, Inc.
Chemistry · 28d
Cleared Feb 25, 1983
TANDEM-E -FER IMMUNOENZYMETRIC KIT
K823871 · DBF
Hybritech, Inc.
Chemistry · 64d
Cleared Feb 25, 1983
ALKALINE PHOSPHATES ISOENZYME SUBSTRATE
K830118 · CIN
Corning Medical & Scientific
Chemistry · 45d
Cleared Feb 25, 1983
TRIGLYCERIDE DIAGNOSTIC KIT
K830288 · CDT
Sclavo, Inc.
Chemistry · 29d
Cleared Feb 25, 1983
STRATUS FLUOROMETRIC ENZYME IMMUN0-
K830301 · JJE
American Hospital Supply Corp.
Chemistry · 28d