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
6169–6192 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Jul 21, 1992
OLYMPUS ISE MODULE
K921718 · JGS
Olympus Corp.
Chemistry · 103d
Cleared Jul 21, 1992
KODAK EKTACHEM DT SLIDES (NBIL)
K921844 · CIG
Eastman Kodak Company
Chemistry · 95d
Cleared Jul 21, 1992
VISTA ULTRASENSITIVE HTSH ASSAY
K922138 · JLW
Syva Co.
Chemistry · 96d
Cleared Jul 21, 1992
VISTA IMMUNOASSAY SYSTEM -- MODIFICATION
K922139 · JJE
Syva Co.
Chemistry · 96d
Cleared Jul 21, 1992
SYNERMED UIBC REAGENT KIT
K922784 · JMO
Synermed, Inc.
Chemistry · 42d
Cleared Jul 17, 1992
TANDEM-E HCG CALIBRATION VERIFICATION CONTROL SET
K920556 · JJX
Hybritech, Inc.
Chemistry · 162d
Cleared Jul 17, 1992
TANDEM-E FERRITIN CALIBRATION VERIFICATION CONROL
K921252 · JJX
Hybritech, Inc.
Chemistry · 123d
Cleared Jul 17, 1992
NOVA 14 NA/K/CL/GLU/BUN ANALYZER
K922215 · JGS
Nova Biomedical Corp.
Chemistry · 84d
Cleared Jul 17, 1992
OLYMPUS ALBUMIN REAGENT
K922369 · CIX
Olympus Corp.
Chemistry · 58d
Cleared Jul 17, 1992
OLYMPUS URIC ACID REAGENT
K922756 · KNK
Olympus Corp.
Chemistry · 38d
Cleared Jul 16, 1992
STAT K SYSTEM
K915345 · CEM
Portable Diagnostic Services, Inc.
Chemistry · 233d
Cleared Jul 16, 1992
OLYMPUS GLUCOSE REAGENT
K922232 · CFR
Olympus Corp.
Chemistry · 65d
Cleared Jul 16, 1992
OLYMPUS TOTAL PROTEIN REAGENT
K922361 · CEK
Olympus Corp.
Chemistry · 58d
Cleared Jul 15, 1992
KING DIAGNOSTICS AST (GOT) REAGENT
K922108 · CIT
King Diagnostics, Inc.
Chemistry · 71d
Cleared Jul 14, 1992
BLOOD GAS/ISE LINEARITY CONTROL
K920285 · JJS
Phoenix Diagnostics, Inc.
Chemistry · 174d
Cleared Jul 14, 1992
WAKO AUTOKIT MICRO TP
K920531 · CEK
Wako Chemicals USA, Inc.
Chemistry · 160d
Cleared Jul 13, 1992
OLYMPUS CREATINE KINASE REAGENT
K922459 · CGS
Olympus Corp.
Chemistry · 48d
Cleared Jul 10, 1992
DSL ACTIVE ALDOSTERONE (DSL 8600)
K921205 · CJM
Diagnostic Systems Laboratories, Inc.
Chemistry · 120d
Cleared Jul 10, 1992
VACUTAINER BRAND LUER ADAPTER
K921520 · JKA
Bd Becton Dickinson Vacutainer...
Chemistry · 101d
Cleared Jul 10, 1992
LYPHOCHEK UNASSAYED CHEMISTRY CONTROL LEVEL 3
K922046 · JJY
Bio-Rad
Chemistry · 70d
Cleared Jul 10, 1992
KODAK EKTACHEM 250 ANALYER
K922072 · JJE
Eastman Kodak Company
Chemistry · 67d
Cleared Jul 10, 1992
OLYMPUS CALCIUM REAGENT
K922233 · CIC
Olympus Corp.
Chemistry · 59d
Cleared Jul 10, 1992
ELEGANCE FT4 ELISA
K922284 · CEC
Bioclone Australia Pty , Ltd.
Chemistry · 56d
Cleared Jul 10, 1992
ANGEL WING SETS -- MODIFIED
K922468 · GIM
Mbo Laboratories, Inc.
Chemistry · 58d