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
7273–7296 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Sep 28, 1989
BLOOD DRAWING NEEDLE
K894374 · FMI
Pharma-Plast USA, Inc.
Chemistry · 73d
Cleared Sep 28, 1989
SINGLE (SPECIFIED) ANALYTE CONTROL (ASSAYED)
K894804 · JJX
Lifescan, Inc.
Chemistry · 62d
Cleared Sep 28, 1989
SERACHEM PLUS CLINICAL CHEMISTRY CONTROLS
K894852 · JJY
Instrumentation Laboratory CO
Chemistry · 59d
Cleared Sep 27, 1989
WAKO(TM) AUTOKIT CRP
K895598 · DCK
Wako Chemicals USA, Inc.
Chemistry · 9d
Cleared Sep 26, 1989
IMX TOTAL B-HCG
K894182 · JHI
Abbott Laboratories
Chemistry · 102d
Cleared Sep 25, 1989
FREE T3 RADIOIMMUNOASSAY KIT
K894200 · CDP
Advanced Magnetics, Inc.
Chemistry · 101d
Cleared Sep 25, 1989
ABBOTT SPECTRUM(R) CALCIUM REAGENT
K894407 · CIC
Abbott Laboratories
Chemistry · 70d
Cleared Sep 18, 1989
BIOTEL MICROALBUMINURIA (TM)
K894169 · JIR
American Diagnostic Corp.
Chemistry · 95d
Cleared Sep 18, 1989
DELFIA FREE THYROXINE (FT4) KIT
K894605 · CEC
Pharmacia, Inc.
Chemistry · 60d
Cleared Sep 18, 1989
MILENIA(TM) PROLACTIN (MKPR1,5)
K895003 · CFT
Diagnostic Products Corp.
Chemistry · 41d
Cleared Sep 15, 1989
BICARBONATE TEST ITEM NUMBER: 65412
K894509 · KHS
Em Diagnostic Systems, Inc.
Chemistry · 58d
Cleared Sep 13, 1989
ABBOTT AST-ACTIVATED (LIQUID, LIST#01A54)
K894180 · CIT
Abbott Laboratories
Chemistry · 89d
Cleared Sep 13, 1989
REP TM SPE (PONCEAU S) PROCEDURES
K894585 · CEF
Helena Laboratories
Chemistry · 51d
Cleared Sep 13, 1989
TANDEM-E FSH IMMUNOENZYMETRIC ASSAY KIT
K894761 · CGJ
Hybritech, Inc.
Chemistry · 48d
Cleared Sep 08, 1989
IMMUNOCOAT PROGESTERONE RADIOIMMUNOASSAY KIT
K894049 · JLS
Pantex, Div. Bio-Analysis, Inc.
Chemistry · 93d
Cleared Sep 07, 1989
PINSET
K884970 · JKA
Safety Diagnostics, Inc.
Chemistry · 281d
Cleared Sep 07, 1989
SAKURA PREP AI AUTOMATIC LIQUID HANDLING SYSTEM
K893811 · JQW
Sakura Finetek U.S.A., Inc.
Chemistry · 108d
Cleared Sep 07, 1989
TRIGLYCERIDE (GPO) TRINDER REAGENT
K894063 · JGY
Sigma Diagnostics, Inc.
Chemistry · 91d
Cleared Sep 07, 1989
NOVA NUCLEUS CLINICAL CHEMISTRY SYSTEM
K894218 · JGS
Nova Biomedical Corp.
Chemistry · 80d
Cleared Sep 07, 1989
DSL 17A-OH PROGERSTERONE (DSL #6800)
K894265 · JLX
Diagnostic Systems Laboratories, Inc.
Chemistry · 77d
Cleared Sep 07, 1989
LACTATE DEHYDROGENASE TEST (LD) ITEM #65418
K894482 · CFJ
Em Diagnostic Systems, Inc.
Chemistry · 51d
Cleared Sep 07, 1989
GLUCOSE-HK TEST (GLU-HK) ITEM #65415
K894483 · CFR
Em Diagnostic Systems, Inc.
Chemistry · 51d
Cleared Sep 05, 1989
CALCIUM TEST ITEM NUMBER: 65409
K893778 · CIC
Em Diagnostic Systems, Inc.
Chemistry · 106d
Cleared Sep 05, 1989
ROCHE REAGENT FOR URIC ACID
K894101 · KNK
Roche Diagnostic Systems, Inc.
Chemistry · 88d