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
7513–7536 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Mar 08, 1989
SERALYZER DIGOXIN ASSAY/TEST MOD/CALIB/CONTR/AMES
K884528 · KXT
Heraeus Kulzer, Inc.
Chemistry · 131d
Cleared Mar 08, 1989
ASPARTATE AMINOTRANSFERASE (AST)
K884724 · CIT
Catachem, Inc.
Chemistry · 118d
Cleared Mar 08, 1989
DELFIA SHBG KIT
K884809 · CDZ
Pharmacia, Inc.
Chemistry · 111d
Cleared Mar 08, 1989
ALKALINE PHOSPHATASE ISOENZYME REAGENTS
K890269 · CIN
Beckman Instruments, Inc.
Chemistry · 49d
Cleared Mar 08, 1989
TOTAL PROTEIN REAGENT
K890317 · CEK
Medical Analysis Systems, Inc.
Chemistry · 44d
Cleared Mar 08, 1989
BIOTROL IRON REAGENT
K890395 · JIY
Biotrol, USA, Inc.
Chemistry · 42d
Cleared Mar 08, 1989
SHAPE-ACTIO URINALYSIS CONTROLS
K890442 · JJY
Actio, Inc.
Chemistry · 40d
Cleared Mar 08, 1989
MODIFIED URIQUAL(TM) URINALYSIS CONTROL LEVEL 1
K890534 · JJW
Fisher Scientific Co., LLC
Chemistry · 41d
Cleared Mar 08, 1989
ESTRADIOL MAIACLONE RADIOIMMUNOASSAY KIT
K890645 · CHP
Serono-Baker Diagnostics, Inc.
Chemistry · 28d
Cleared Mar 08, 1989
STATSPIN HDL-CHOLESTEROL PRECIPITATING MICRO TUBE
K890669 · LBR
Norfolk Scientific, Inc.
Chemistry · 27d
Cleared Mar 06, 1989
TOTAL BILIRUBIN REAGENT, CONCENTRATED
K890070 · CIG
Trace Scientific , Ltd.
Chemistry · 56d
Cleared Feb 27, 1989
DACOS OR DACOS XL CLINICAL CHEMISTRY ANALYZER
K884378 · JJE
Coulter Corp.
Chemistry · 132d
Cleared Feb 27, 1989
MODIFIED FREE T4 RADIOIMMUNOASSAY KIT
K884753 · CEC
Advanced Magnetics, Inc.
Chemistry · 105d
Cleared Feb 27, 1989
CALCIUM PLUS PROCEDURE
K890302 · CJY
Data Medical Associates, Inc.
Chemistry · 35d
Cleared Feb 27, 1989
GLUCOSE (GOD) REAGENT
K890336 · CGA
Alpkem Corp.
Chemistry · 35d
Cleared Feb 27, 1989
MICROLITE TUBE LUMINOMETER #011-902-0000
K890502 · JJQ
Dynatech Laboratories, Inc.
Chemistry · 26d
Cleared Feb 27, 1989
ABBOTT CLINICAL CHEMISTRY REAGENT CK-NAC
K890540 · CGS
Abbott Laboratories
Chemistry · 24d
Cleared Feb 23, 1989
THYROXINE MICROASSAY
K884260 · KLI
Diamedix Corp.
Chemistry · 135d
Cleared Feb 23, 1989
CREATINE KINASE MB ENZYME IMMUNOASSAY KIT
K884550 · JHY
Bd Becton Dickinson Vacutainer...
Chemistry · 115d
Cleared Feb 23, 1989
DSL 7800 ACTIVE CORTISOL
K884689 · CGR
Diagnostic Systems Laboratories, Inc.
Chemistry · 107d
Cleared Feb 23, 1989
17-ALPHA-HYDROXYPROGESTERONE (17-OH-P) NEO. RIA
K885198 · JLX
Icn Biomedicals, Inc.
Chemistry · 69d
Cleared Feb 23, 1989
TITAN GEL ALKALINE PHOSPHATASE (HR)
K885341 · CIN
Helena Laboratories
Chemistry · 57d
Cleared Feb 23, 1989
SAFEPETTE DISPENSER
K890109 · JKA
Safe-Tec Clinical Products, Inc.
Chemistry · 44d
Cleared Feb 23, 1989
DELFIA PROGESTERONE KIT
K890428 · JLS
Pharmacia, Inc.
Chemistry · 28d