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
7249–7272 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Oct 16, 1989
MODEL 100 PORTABLE CLINICAL ANALYZER AND TEST PACK
K894914 · JGS
I-Stat Corp.
Chemistry · 75d
Cleared Oct 16, 1989
COBAS READY GLUCOSE REAGENT
K895526 · CGA
Roche Diagnostic Systems, Inc.
Chemistry · 34d
Cleared Oct 12, 1989
CREATININE FOR MANUAL OR AUTOMATED APPLICATIONS
K894389 · GGX
Catachem, Inc.
Chemistry · 87d
Cleared Oct 12, 1989
CALCIUM (ARSENAZO III) FOR MANUAL/AUTO APPLICATION
K894476 · CJY
Catachem, Inc.
Chemistry · 86d
Cleared Oct 12, 1989
CLEARPLAN EASY
K894579 · CEP
Unipath , Ltd.
Chemistry · 80d
Cleared Oct 12, 1989
CIBA CORNING MAGIC LITE PROLACTIN IMMUNOASSAY
K894988 · CFT
Ciba Corning Diagnostics Corp.
Chemistry · 65d
Cleared Oct 06, 1989
FIRST CHOICE (TM)
K893205 · CGA
Polymer Technology Corp.
Chemistry · 163d
Cleared Oct 06, 1989
HIGH PRESSURE INERT PLASTIC COLUMNS FOR CLIN. USE
K895105 · DPM
Waters Chemical Products
Chemistry · 52d
Cleared Oct 06, 1989
BIOTRACK ALT TEST CARTRIDGE
K895128 · CJJ
Biotrack, Inc.
Chemistry · 50d
Cleared Oct 06, 1989
ABL500 BLOOD GAS SYSTEM
K895181 · CHL
Radiometer America, Inc.
Chemistry · 56d
Cleared Oct 04, 1989
PRO-JECT(TM) SAFETY NEEDLE HOLDER
K892665 · JKA
Pro-Tec Containers, Inc.
Chemistry · 174d
Cleared Oct 04, 1989
CALCIUM (ARSENAZO III) REAGENT
K894204 · CJY
Sigma Diagnostics, Inc.
Chemistry · 107d
Cleared Oct 04, 1989
ORTHO RESULT PLUS/PREGNANCY
K894420 · JHI
Ortho Diagnostic Systems, Inc.
Chemistry · 79d
Cleared Oct 04, 1989
TECHNICON RA SYSTEM THYROXINE T4 METHOD
K894575 · CDX
Technicon Instruments Corp.
Chemistry · 75d
Cleared Oct 04, 1989
DELFIA PLATE FLUOROMETER 1232
K895240 · KHO
Pharmacia, Inc.
Chemistry · 44d
Cleared Oct 04, 1989
ACCESS CHEMISTRY ANALYZER
K895423 · JJE
American Monitor Corp.
Chemistry · 27d
Cleared Oct 04, 1989
QCLYTE PROTEIN-BASED ISE CONTROL
K895582 · JJR
Baxter Healthcare Corp
Chemistry · 19d
Cleared Oct 03, 1989
ABBOTT SPECTRUM GLUCOSE-HEXOKINASE REAGENT
K894394 · CFR
Abbott Laboratories
Chemistry · 78d
Cleared Oct 02, 1989
VISION WHOLE BLOOD HDL CHOLESTEROL
K895158 · CHH
Abbott Laboratories
Chemistry · 53d
Cleared Sep 28, 1989
COAT-A-COUNT(TM) FENTANYL (TKFN1)
K891605 · DJG
Diagnostic Products Corp.
Chemistry · 192d
Cleared Sep 28, 1989
KIT- CIBA CORNING L-TDM I, II, III
K893682 · DIF
Ciba Corning Diagnostics Corp.
Chemistry · 135d
Cleared Sep 28, 1989
DELTATEST (R) LIPASE II
K893718 · CET
Electro-Nucleonics, Inc.
Chemistry · 134d
Cleared Sep 28, 1989
AMRESCO TRIGLYCERIDES REAGENTS (PRODUCTS 7730)
K894310 · CDT
American Research Products Co.
Chemistry · 76d
Cleared Sep 28, 1989
NIPRO NEEDLE HOLDER
K894372 · FMI
Pharma-Plast USA, Inc.
Chemistry · 73d