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
6361–6384 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Dec 18, 1991
GAS TRAK CONNECT BLOOD GAS CONTROL
K914099 · JPK
Biochemical Sciences, Inc.
Chemistry · 97d
Cleared Dec 18, 1991
IN VITRO DIAGNOSTIC REGEANT SET,CHOLINESTERASE
K914171 · DIH
Tech Intl. Co.
Chemistry · 92d
Cleared Dec 18, 1991
TECHNICON CHEM 1 PLASMA GLUCOSE
K914794 · CFR
Heraeus Kulzer, Inc.
Chemistry · 56d
Cleared Dec 18, 1991
SYNCHRON CREATININE TRIGGERED TEST CX4,5,7,
K915077 · CGX
Beckman Instruments, Inc.
Chemistry · 40d
Cleared Dec 18, 1991
RAI-TROL ELEVATED LIPIDS CONTROL
K915191 · JJY
Reagents Applications, Inc.
Chemistry · 29d
Cleared Dec 18, 1991
FSH ENZYME IMMUNASSAY TEST KIT NO:KIF4057
K915208 · CGJ
Medix Biotech, Inc.
Chemistry · 30d
Cleared Dec 17, 1991
LUMATAG FREE T4 CHEMILUMINESCENCE ASSAY
K914835 · CEC
London Diagnostics, Inc.
Chemistry · 53d
Cleared Dec 17, 1991
PRECISE TM HCG
K915197 · JHI
Becton Dickinson Advanced Diagnostics
Chemistry · 28d
Cleared Dec 16, 1991
PRECISE TM HCG FOR USE IN THE PHYSICIANS OFFICE LA
K915200 · JHI
Becton Dickinson Advanced Diagnostics
Chemistry · 27d
Cleared Dec 13, 1991
IMMUCHEM NEONATAL TSH-MP ELISA
K913963 · JLW
Icn Biomedicals, Inc.
Chemistry · 99d
Cleared Dec 13, 1991
CREATINE KINASE MB TEST ITEM NUMBER 5A46
K914361 · CGS
Em Diagnostic Systems, Inc.
Chemistry · 73d
Cleared Dec 13, 1991
DU PONT TOTAL PROTEIN/ALBUMIN CALIBRATOR
K914917 · JIX
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 39d
Cleared Dec 09, 1991
CEDIA T4
K915194 · KLI
Boehringer Mannheim Corp.
Chemistry · 20d
Cleared Dec 04, 1991
EASYLYTE SODIUM/POTASSIUM/LITHIUM ANALYZER
K914810 · JGS
Medica Corp.
Chemistry · 40d
Cleared Dec 04, 1991
DIAZO COLORIMETRY, BILIRUBIN
K914873 · CIG
Pointe Scientific, Inc.,
Chemistry · 36d
Cleared Nov 29, 1991
STAT PAL SENSYR SYRINGE ASSEMBLY FOR USE W/STATPAL
K914560 · CHL
Ppg Industries, Inc.
Chemistry · 45d
Cleared Nov 27, 1991
REP(R) SPE TEMPLATE 30, 16, & 8
K913807 · CEF
Helena Laboratories
Chemistry · 93d
Cleared Nov 27, 1991
COULTER CARBON DIOXIDE REAGENT
K914486 · KHS
Coulter Corp.
Chemistry · 50d
Cleared Nov 27, 1991
DIMENSION(R) LACTIC ACID METHOD
K914508 · KHP
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 49d
Cleared Nov 27, 1991
TECHNICON AXON(TM) SYSTEM METHODS ANYALYE HDL CHOL
K914511 · LBS
Technicon Instruments Corp.
Chemistry · 49d
Cleared Nov 27, 1991
TECHNICON CHEM 1(TM) SYST (GEN2 SYST)
K914888 · CIX
Technicon Instruments Corp.
Chemistry · 28d
Cleared Nov 27, 1991
AUTO EIA MICROPLATE READ MODEL CERES 900 W/VAR OPT
K914906 · JJQ
Bio-Tek Instruments, Inc.
Chemistry · 26d
Cleared Nov 22, 1991
UROTEST GPH
K912244 · JII
In Wha Pharmaceutical Co., Ltd.
Chemistry · 185d
Cleared Nov 22, 1991
ABBOTT QUICKSTART ALKA PHOSPHATASE (ALP) ITEM#5A38
K913921 · CJE
Em Diagnostic Systems, Inc.
Chemistry · 80d