FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,218 clearances · 1976 to present · Updated monthly from FDA records

Filters: Chemistry ×
13,224 results
10633–10656 of 13,224
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Feb 18, 1983
BLOOD GAS INCUBATOR #260650
K823766 · JRG
Boekel Industries, Inc.
Chemistry · 66d
Cleared Feb 18, 1983
NO BOIL DUAL COUNT VIT-B12 & FOLIC ACID
K830195 · CDD
Diagnostic Products Corp.
Chemistry · 29d
Cleared Feb 18, 1983
DAC-CEL DIAGNATAL RD 50
K830203 · JHI
Wellcome Diagnostics
Chemistry · 29d
Cleared Feb 18, 1983
DAC-CEL DIAGNATAL HCG STANDARDS RD49
K830204 · JJX
Wellcome Diagnostics
Chemistry · 29d
Cleared Feb 18, 1983
TDX N-ACETYLPROCAINAMIDE
K830206 · LAN
Abbott Laboratories
Chemistry · 28d
Cleared Feb 18, 1983
REAGENTS CORNING CHLORIDE METER FOR
K830217 · JFS
Fisher Scientific Co., LLC
Chemistry · 25d
Cleared Feb 18, 1983
ULTRA CHEM CRESOLCAVERSACHEM #65082
K830238 · CIC
Emd Chemicals, Inc.
Chemistry · 24d
Cleared Feb 18, 1983
ULTRAZYME PLUS GAMMA GT-MCA #65055-65056
K830240 · JQB
Emd Chemicals, Inc.
Chemistry · 24d
Cleared Feb 18, 1983
CAST SHOE, CAST BOOT
K830246 · JQB
Warm & Form, Orthopedic Materials
Chemistry · 24d
Cleared Feb 16, 1983
MICROELISA MINIREADER II
K830200 · LBI
Dynatech Corp.
Chemistry · 27d
Cleared Feb 09, 1983
APSARA CLINICAL DIAG. & INFO. SYS
K823386 · JJE
Datachem, Inc.
Chemistry · 86d
Cleared Feb 09, 1983
CORTISOL KIT
K830148 · CGR
Cambridge Medical Technology
Chemistry · 23d
Cleared Feb 09, 1983
HCG SCREENING TEST
K830156 · JHJ
Tago, Inc.
Chemistry · 22d
Cleared Feb 07, 1983
IMMU-TRACE TRI-RAC R TRI-LEVEL CONTROLS
K823352 · JJY
American Dade
Chemistry · 90d
Cleared Feb 07, 1983
PARAMOUNT THYROXINE ASSAY
K830136 · KLI
Syva Co.
Chemistry · 25d
Cleared Feb 07, 1983
CALIBRATOR A
K830137 · JIS
Hi Chem, Inc.
Chemistry · 25d
Cleared Feb 07, 1983
TANDEM E GCG VISUAL END POINT INNUMOENZ
K830138 · JHI
Hybritech, Inc.
Chemistry · 25d
Cleared Feb 07, 1983
RIASSIST RAST DATA REDUCTION/QUALITY
K830170 · DHB
Ventrex Laboratories, Inc.
Chemistry · 20d
Cleared Feb 02, 1983
SODIUM/POTASSIUM/IONIZED CALCIUM ANALYZ
K823389 · JFP
Nova Biomedical Corp.
Chemistry · 79d
Cleared Jan 28, 1983
URITEST 9, INLAB REAGENT STRIPS URINALY
K822709 · JMA
Laprol Scientific, Inc.
Chemistry · 143d
Cleared Jan 28, 1983
CYCLIC ADENOSINE MONOPHOSHATE BY RADIO
K823504 · CHO
Immuno Nuclear Corp.
Chemistry · 65d
Cleared Jan 28, 1983
ULTRAZYME PLUS GAMMA-GT, #64959/65032
K823883 · JQB
Emd Chemicals, Inc.
Chemistry · 32d
Cleared Jan 28, 1983
MULTIANALYTE CONTROLS-ALL KINDS
K823929 · JJY
Fisher Scientific Co., LLC
Chemistry · 30d
Cleared Jan 28, 1983
WAKO INSULIN TEST
K823939 · CFP
Wako Chemicals USA, Inc.
Chemistry · 30d