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
7561–7584 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Feb 07, 1989
STANBIO MAGNESIUM TEST SET, CAT. NO 0130
K883170 · JGJ
Stanbio Laboratory
Chemistry · 195d
Cleared Feb 07, 1989
OLYMPUS TRIGLYCERIDES REAGENTS #SR1021
K885266 · CDT
Em Diagnostic Systems, Inc.
Chemistry · 47d
Cleared Feb 07, 1989
HIGH VOLUME PROFILER & DATA ENHANCEMENT PACKAGE
K885288 · JJE
Eastman Kodak Company
Chemistry · 42d
Cleared Feb 07, 1989
KODAK EKTACHEM 700 ANALYZER FAMILY, SOFT V5.0
K885289 · JJE
Eastman Kodak Company
Chemistry · 42d
Cleared Feb 07, 1989
MODIFIED INTENDED USE ON CLEANING NEUTRALIZER SOL.
K890183 · JJE
Hichem Diagnostics
Chemistry · 20d
Cleared Feb 07, 1989
MODIFIED INTENDED USE OF CLEANING REAGENT KIT
K890184 · JJE
Hichem Diagnostics
Chemistry · 20d
Cleared Feb 03, 1989
LYTENING 6 SODIUM/POTASSIUM/IONIZED CALCIUM ANALYZ
K884731 · JFP
Amdev, Inc.
Chemistry · 85d
Cleared Feb 03, 1989
OLYMPUS ISE MODULE
K885193 · CGZ
Olympus Corp.
Chemistry · 49d
Cleared Feb 03, 1989
PHOTOMETRIC METHOD, IRON (NON-HEME) (75JIY)
K890034 · JIY
American Monitor Corp.
Chemistry · 30d
Cleared Feb 02, 1989
GLUCOSE-SUPER FAST 4983050 AND 4983500
K882262 · CGA
American Research Products Co.
Chemistry · 247d
Cleared Feb 02, 1989
CREATINE KINASE TEST (CK) ITEM NUMBER: 65661
K884546 · CGS
Em Diagnostic Systems, Inc.
Chemistry · 94d
Cleared Feb 02, 1989
PROGESTERONE SEROZYME IMMUNOENZYMETRIC ASSAY
K884794 · JLS
Serono-Baker Diagnostics, Inc.
Chemistry · 78d
Cleared Feb 02, 1989
MODEL 250 LIQUID CHROMOTAGRAPHY PUMP
K884886 · LDM
The Perkin-Elmer Corp.
Chemistry · 72d
Cleared Feb 02, 1989
T-UPTAKE MICROASSAY
K885034 · CEE
Diamedix Corp.
Chemistry · 59d
Cleared Feb 02, 1989
CLINISTAT SGPT (ALT) SERUM GLUTAMATE PYRUVATE TRAN
K885144 · CKA
Heraeus Kulzer, Inc.
Chemistry · 49d
Cleared Feb 02, 1989
CLINISTAT SGOT (AST) REAGENT TEST
K885156 · CIT
Heraeus Kulzer, Inc.
Chemistry · 49d
Cleared Jan 30, 1989
PREGNA-CARD(TM) A VISUAL HOME PREGNANCY TEST
K883430 · LCX
Disease Detection International, Inc.
Chemistry · 168d
Cleared Jan 30, 1989
TECHNICON CHEM 1 SYSTEM ACID PHOSPHATASE (TOTAL)
K884747 · CKB
Technicon Instruments Corp.
Chemistry · 77d
Cleared Jan 30, 1989
TECHNICON CHEM 1 SYSTEM ACID PHOS (PROSTATIC)
K884748 · JFH
Technicon Instruments Corp.
Chemistry · 77d
Cleared Jan 30, 1989
BIOTROL INORGANIC PHOSPHORUS
K885041 · CEO
Biotrol, USA, Inc.
Chemistry · 56d
Cleared Jan 30, 1989
BIOTROL URINE PROTEINS REAGENT
K885053 · JIR
Biotrol, USA, Inc.
Chemistry · 54d
Cleared Jan 30, 1989
TOTAL BILIRUBIN TEST CATALOG NO. SR1007
K885284 · CIG
Em Diagnostic Systems, Inc.
Chemistry · 38d
Cleared Jan 30, 1989
DIRECT BILIRUBIN TEST CATALOG NO. SR1008
K885285 · CIG
Em Diagnostic Systems, Inc.
Chemistry · 38d
Cleared Jan 27, 1989
UB ANALYZER, MODEL UA-1/REAGENT KIT/BILIRUBIN CON.
K871115 · CIG
Labo Science-USA, Inc.
Chemistry · 680d