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
6505–6528 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Jul 30, 1991
SYNERMED SERUM IRON-600 REAGENT KIT
K912912 · CFM
Synermed, Inc.
Chemistry · 27d
Cleared Jul 30, 1991
MILENIA ESTRADIOL
K912917 · CHP
Diagnostic Products Corp.
Chemistry · 27d
Cleared Jul 26, 1991
ROBOTIC SAMPLE PROCESSOR
K912036 · JQW
Tecan U.S., Ltd.
Chemistry · 79d
Cleared Jul 26, 1991
MAGNESIUM ASSAY KIT, CAT.# 100-12
K912825 · JGJ
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 30d
Cleared Jul 26, 1991
WHOLE BLOOD ALCOHOL CONTROL, LEVEL 1 & 2
K912826 · DKC
Cala Diagnostics
Chemistry · 30d
Cleared Jul 26, 1991
MICROTRAK MANAGER
K912959 · JJQ
Syva Co.
Chemistry · 18d
Cleared Jul 26, 1991
ABBOTT QUICKSTART GAMMA-GLUTAMYTRANSFERASE TEST
K913024 · JQB
Em Diagnostic Systems, Inc.
Chemistry · 17d
Cleared Jul 25, 1991
ESTRADIOL SEROZYME ENZYME IMMUNO (MAG SOLID-PHASE)
K912318 · CHP
Serono-Baker Diagnostics, Inc.
Chemistry · 62d
Cleared Jul 24, 1991
QUIKPAC-II ONE STEP PREGNANCY HOME TEST
K912316 · LCX
Syntron Bioresearch, Inc.
Chemistry · 61d
Cleared Jul 22, 1991
AMERLEX-M SPECIFIC ESTROL(UNCONJUGATED) RIA KIT
K912733 · CIG
Amersham Corp.
Chemistry · 32d
Cleared Jul 19, 1991
IMMUNOCARD HCG ONE STEP (I-S) TEST KIT
K911826 · JHI
Disease Detection International, Inc.
Chemistry · 86d
Cleared Jul 19, 1991
ROCHE REAGENT FOR C02
K911838 · CHS
Roche Diagnostic Systems, Inc.
Chemistry · 85d
Cleared Jul 19, 1991
AUTOMATED BIOCHEMICAL ANALYZER (WAK0-20R & 30R)
K912024 · JJE
Wako Chemicals USA, Inc.
Chemistry · 77d
Cleared Jul 19, 1991
TARGET MICROALBUMINURIA TEST
K912246 · JIR
Texas Immunology, Inc.
Chemistry · 59d
Cleared Jul 19, 1991
ELECTROLYTE CONTROL
K912513 · JJR
Verichem Laboratories, Inc.
Chemistry · 43d
Cleared Jul 19, 1991
MICRO ALBUMIN EIA TEST KIT
K912543 · JIR
Immuno Diagnostic Center, Inc.
Chemistry · 39d
Cleared Jul 18, 1991
MAGNETIC HDL CHOLESTEROL TEST
K911906 · LBR
Reference Diagnostics, Inc.
Chemistry · 79d
Cleared Jul 18, 1991
KING DIAGNOSTICS GLUCOSE (HK) REAGENT STRIP TEST
K912251 · CFR
King Diagnostics, Inc.
Chemistry · 58d
Cleared Jul 18, 1991
CALCITONIN KIT MITSUBISHI YUKA
K912536 · JKR
Mitsubishi Yuka America, Inc.
Chemistry · 41d
Cleared Jul 17, 1991
VISION BG TEST STRIP
K911624 · CGA
British-American Medical, Inc.
Chemistry · 97d
Cleared Jul 17, 1991
TRACE TOTAL/DIRECT BILIRUBIN REAGENT
K911866 · CIG
Trace Scientific , Ltd.
Chemistry · 82d
Cleared Jul 17, 1991
REP SPE PLUS (PONCEAU S) SYSTEM, 3163, 3164 & 3165
K912386 · CEF
Helena Laboratories
Chemistry · 82d
Cleared Jul 17, 1991
ULTRA BLOOD GLUCOSE MONITORING SYSTEM
K912440 · CGA
Home Diagnostics, Inc.
Chemistry · 44d
Cleared Jul 17, 1991
LINEARITY TEST KITS
K912441 · JJY
Boehringer Mannheim Corp.
Chemistry · 44d