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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Chemistry ×
13,237 results
5281–5304 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Feb 22, 1995
RADIAS TOTAL T4 ENZYME IMMUNOASSAY
K946163 · KLI
Bio-Rad
Chemistry · 65d
Cleared Feb 22, 1995
CLINITEK ATLAS AUTOMATED URINE CHEMISTRY ANALYZER
K946183 · KQO
Heraeus Kulzer, Inc.
Chemistry · 64d
Cleared Feb 22, 1995
DSL ACTIVE IGFBP-3 IRMA (DSL 6600)
K950228 · CFL
Diagnostic Systems Laboratories, Inc.
Chemistry · 42d
Cleared Feb 22, 1995
RNA MEDICAL'S EQUIL PLUS WITH GLUCOSE CONTROL
K950399 · JJY
Bionostics, Inc.
Chemistry · 21d
Cleared Feb 13, 1995
DSL ACTIVE ALDOSTERONE RIA (DSL 8600)
K943397 · CJM
Diagnostic Systems Laboratories, Inc.
Chemistry · 214d
Cleared Feb 10, 1995
TINA-QUANT MICROALBUMIN
K932950 · JIR
Boehringer Mannheim Corp.
Chemistry · 603d
Cleared Feb 10, 1995
QUICK CHECKER HCG PREGNANCY TEST
K943859 · JHI
Mizuho USA, Inc.
Chemistry · 186d
Cleared Feb 10, 1995
ACE IRON REAGENT
K944911 · JIY
Schiapparelli Biosystems, Inc.
Chemistry · 128d
Cleared Feb 10, 1995
ALKO CAL PACKS FOR CORNING 654 ANALYZERS
K944922 · JIX
Alko Diagnostic Corp.
Chemistry · 127d
Cleared Feb 10, 1995
LIFESIGN(TM) 1, BIOSIGN(TM) 1, LIFESIGN PLUS(TM), LIFESIGN(TM) HCG
K945514 · LCX
Princeton BioMeditech Corp.
Chemistry · 93d
Cleared Feb 10, 1995
ALKO CALIBRATORS AND FLUSH SOLUTION FOR IL 1300 SERIES PH/BLOOD GAS ANALYZERS
K945966 · JIX
Alko Diagnostic Corp.
Chemistry · 65d
Cleared Feb 10, 1995
LIQUISPEX(TM) LIQUID B2M/CRP CONTROL LEVEL 1 AND 2
K946049 · JJY
Clinical Controls, Inc.
Chemistry · 60d
Cleared Feb 08, 1995
IMMUCHEM PHE-MW EA
K926106 · JNB
Icn Biomedicals, Inc.
Chemistry · 797d
Cleared Feb 08, 1995
TDX(R)/TDXFLX(R) FETAL LUNG MATURITY II
K940817 · JHF
Abbott Laboratories
Chemistry · 351d
Cleared Feb 08, 1995
UREA NITROGEN REAGENT
K944250 · CDQ
Olympus Corp of America
Chemistry · 160d
Cleared Feb 08, 1995
CATALOGUE NUMBER 321-07/15/50
K945243 · JFJ
Diagnostic Chemicals , Ltd.
Chemistry · 104d
Cleared Feb 08, 1995
NOVA 16 ANALYZER
K945584 · JJC
Nova Biomedical Corp.
Chemistry · 86d
Cleared Feb 08, 1995
QUIKPAC II, ONE STEP HCG COMBO KIT
K945951 · JHI
Syntron Bioresearch, Inc.
Chemistry · 64d
Cleared Feb 07, 1995
WAKO MICRO-ALBUMIN B/WAKO MICRO ALBUMIN CALIBRATOR
K944664 · JIQ
Wako Chemicals USA, Inc.
Chemistry · 138d
Cleared Feb 06, 1995
CERES 900C & CERES UV900C
K942923 · JJQ
Bio-Tek Instruments, Inc.
Chemistry · 230d
Cleared Feb 06, 1995
VACUTAINER BRAND SAFETY-GARD PHLEBOTOMY SYSTEM
K945458 · GIM
Bd Becton Dickinson Vacutainer...
Chemistry · 91d
Cleared Feb 03, 1995
RADIAS RED CELL FOLATE IMMUNOASAY
K944212 · CGN
Bio-Rad
Chemistry · 158d
Cleared Feb 03, 1995
CHEMSPEX(TM) AMMONIA CONTROL
K946143 · JJX
Clinical Controls, Inc.
Chemistry · 49d
Cleared Jan 30, 1995
DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER
K943493 · JJE
Hamilton Co.
Chemistry · 195d