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
7225–7248 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Oct 25, 1989
PLASMA CATECHOLAMINES BY HPLC
K894966 · CHQ
Bio-Rad
Chemistry · 79d
Cleared Oct 25, 1989
GEL ALKALINE PHOSPHATASE ISOENZYME CONTROL NO.5104
K895528 · JJX
Helena Laboratories
Chemistry · 49d
Cleared Oct 25, 1989
TECHNICON DAX SYSTEM - SODIUM (ISE) METHOD
K895672 · JGS
Technicon Instruments Corp.
Chemistry · 35d
Cleared Oct 23, 1989
GLYCABEN
K893453 · LCP
Exocell, Inc.
Chemistry · 173d
Cleared Oct 23, 1989
MICRO-PLATE READER, MDX-1
K894400 · JJX
Medix Biotech, Inc.
Chemistry · 96d
Cleared Oct 23, 1989
MILENIA(TM) CORTISOL (MKCO1,5)
K895006 · CGR
Diagnostic Products Corp.
Chemistry · 76d
Cleared Oct 23, 1989
SYSTEMATE CREATININE TEST (CREA) #65413
K895022 · CGX
Em Diagnostic Systems, Inc.
Chemistry · 76d
Cleared Oct 23, 1989
FOLLICLE STIMULATING HORMONE MAB SOLID PHASE COM.
K895108 · CGJ
Bd Becton Dickinson Vacutainer...
Chemistry · 69d
Cleared Oct 23, 1989
HI CHEM CALIBRATOR A+
K895135 · JIX
Hichem Diagnostics
Chemistry · 68d
Cleared Oct 23, 1989
URIC ACID PAP
K895665 · KNK
Boehringer Mannheim Corp.
Chemistry · 33d
Cleared Oct 19, 1989
CLINISTAT LDH REAGENT TEST
K895138 · CFH
Heraeus Kulzer, Inc.
Chemistry · 64d
Cleared Oct 19, 1989
CORTISOL CLASP-BEAD EIA KIT
K895407 · CGR
Biotecx Laboratories, Inc.
Chemistry · 43d
Cleared Oct 19, 1989
LITHIUM CONCENTRATE FOR A FLAME PHOTOMETER
K895718 · JGM
Data Medical Associates, Inc.
Chemistry · 24d
Cleared Oct 19, 1989
MILENIA(TM) TOTAL T4 (MKT41,5)
K895840 · CDP
Diagnostic Products Corp.
Chemistry · 16d
Cleared Oct 18, 1989
BIOSPOT HCG-RAPID PREGNANCY TEST
K894705 · JHI
Princeton Biomedix
Chemistry · 85d
Cleared Oct 18, 1989
BIOSTIX I. HCG - ONE STEP PREGNANCY TEST
K894750 · JHI
Princeton Biomedix
Chemistry · 84d
Cleared Oct 17, 1989
IMMULON 1,2,3,AND 4 DIVIDASTRIPS TM
K894645 · JTC
Dynatech Laboratories, Inc.
Chemistry · 85d
Cleared Oct 17, 1989
CLINISTAT POTASSIUM REAGENT TEST
K895047 · CFM
Heraeus Kulzer, Inc.
Chemistry · 69d
Cleared Oct 17, 1989
SYSTEMATE TOTAL BILIRUBIN CATALOG NO. 65407
K895118 · CIG
Em Diagnostic Systems, Inc.
Chemistry · 63d
Cleared Oct 17, 1989
SYSTEMATE DIRECT BILIRUBIN CATALOG NO. 65406
K895119 · CIG
Em Diagnostic Systems, Inc.
Chemistry · 63d
Cleared Oct 17, 1989
MICROLITE ML 1000 (MODEL 3) MICROPLATE LUMINOMETER
K895313 · JJQ
Dynatech Laboratories, Inc.
Chemistry · 49d
Cleared Oct 17, 1989
SR1 PROLACTIN (PRL IMMUNOENZYMETRIC ASSAY
K895380 · CFT
Serono-Baker Diagnostics, Inc.
Chemistry · 48d
Cleared Oct 17, 1989
BETA2 M-TRAC BY ENZYME BEAD-BASED IMMUNOASSAY EIA
K895496 · JZG
Incstar Corp.
Chemistry · 69d
Cleared Oct 16, 1989
CLP CK/LD ISOENZYME CONTROL
K894554 · JJT
Creative Laboratory Products, Inc.
Chemistry · 88d