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
5713–5736 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Nov 10, 1993
FREE THYROXINE(F T4) METHOD/TECHNICON IMMUNO 1(R)
K930322 · CEC
Heraeus Kulzer, Inc.
Chemistry · 292d
Cleared Nov 10, 1993
AUTOBEAD THYROID UPTAKE
K930689 · KHO
Bio-Chem Laboratory Systems, Inc.
Chemistry · 273d
Cleared Nov 09, 1993
AIA-PACK E2 ASSAY
K932084 · CHP
Tosoh Medics, Inc.
Chemistry · 193d
Cleared Nov 09, 1993
IRON/UIBC REAGENT
K932517 · JMO
Sigma Diagnostics, Inc.
Chemistry · 168d
Cleared Nov 09, 1993
CHOLESTECH L.D.X. SYSTEM
K932727 · CGA
Cholestech Corp.
Chemistry · 158d
Cleared Nov 09, 1993
BECKMAN SYNCHRON LACTATE REAGENT
K934271 · KHP
Beckman-Diagnostic Systems Group
Chemistry · 70d
Cleared Nov 05, 1993
AMYLASE REAGENT SET (KINETIC)
K931080 · JFJ
Teco Diagnostics
Chemistry · 248d
Cleared Nov 05, 1993
KINGS BAY PRELUDE ONE STEP HCG COMBO KIT
K931698 · JHI
King'S Bay Intl., Inc.
Chemistry · 213d
Cleared Nov 05, 1993
ILAB 900/1800 CLINICAL CHEMISTRY SYSTEM
K932467 · JJQ
Instrumentation Laboratory CO
Chemistry · 165d
Cleared Nov 05, 1993
SYNELISA PROGESTERONE
K933128 · JLS
Elias U.S.A., Inc.
Chemistry · 130d
Cleared Nov 05, 1993
ACCESS VITAMIN B12 ASSAY
K933142 · CDD
Bio-Rad Laboratories, Inc.
Chemistry · 130d
Cleared Nov 05, 1993
OLYMPUS CHLORIDE REAGENT, MODIFICATION
K934136 · CHJ
Olympus Corp.
Chemistry · 78d
Cleared Nov 05, 1993
N-ASSAY TIA MICROALBUMIN CALIBRATOR SET
K934143 · JIX
Crestat Diagnostics, Inc.
Chemistry · 73d
Cleared Oct 29, 1993
ELS 1000
K933548 · JJE
Bio-Tek Instruments, Inc.
Chemistry · 101d
Cleared Oct 28, 1993
DMA AMYLASE PROCEDURE
K931559 · CIW
Data Medical Associates, Inc.
Chemistry · 212d
Cleared Oct 28, 1993
CARDIO REP RECOMBINANT CK ABNORMAL CONTROL
K932442 · JJT
Helena Laboratories
Chemistry · 161d
Cleared Oct 28, 1993
LD-1 ISOENZYME CONTROL (HUMAN) LEVEL 1 & 2
K932660 · JJX
More Diagnostics
Chemistry · 148d
Cleared Oct 28, 1993
STRATUS FREE THYROXINE (FREE T4) FLUOROMETRIC
K932912 · CEC
Baxter Diagnostics, Inc.
Chemistry · 134d
Cleared Oct 28, 1993
SYNERMED DIRECT BILIRUBIN REAGENT KIT
K933026 · CIG
Synermed, Inc.
Chemistry · 128d
Cleared Oct 28, 1993
GENZYME A-AMYLASE TEST REAGENT
K933397 · JFJ
Genzyme Corp.
Chemistry · 108d
Cleared Oct 28, 1993
DADE ANEMIA/HEMOCHROMATOSIS CONTOLS,LEVEL 1,LEVEL 2,AND LEVEL 3
K933437 · JJY
Baxter Diagnostics, Inc.
Chemistry · 106d
Cleared Oct 28, 1993
BECKMAN CHOLESTEROL REAGENT
K934046 · CHH
Beckman-Diagnostic Systems Group
Chemistry · 70d
Cleared Oct 22, 1993
PROGESTERONE RADIOIMMUNOASSAY KIT
K931228 · JLS
Immunotech Corp.
Chemistry · 226d
Cleared Oct 22, 1993
AIA-PACK(R) PROG ASSAY
K933269 · JLS
Tosoh Medics, Inc.
Chemistry · 108d