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
5209–5232 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Apr 20, 1995
BIONIKE A/Q PREGNANCY TEST
K951136 · JHI
Charlton Assoc.
Chemistry · 38d
Cleared Apr 20, 1995
VIGIL MULTICHEK CONTROLS
K951170 · JJY
Beckman Instruments, Inc.
Chemistry · 36d
Cleared Apr 20, 1995
QUANTITATE ENZYME VERIFIER SET
K951293 · JJT
Beckman Instruments, Inc.
Chemistry · 29d
Cleared Apr 14, 1995
LEUR TIP CAP, VLT CAP(TM)
K945454 · JKA
Martell Medical Products, Inc.
Chemistry · 158d
Cleared Apr 14, 1995
MULTIPLE (IZON DBS & URINE COLLECTION KIT)
K950257 · JXA
Izon Business Products, Inc.
Chemistry · 81d
Cleared Apr 13, 1995
PICCOLO(TM) PRIMARY HEALTH PANEL REAGENT ROTOR
K950164 · CHH
Abaxis, Inc.
Chemistry · 86d
Cleared Apr 13, 1995
ELSA-PTH
K950211 · CEW
Cis-Us, Inc.
Chemistry · 84d
Cleared Apr 13, 1995
MULTI-DRUG CONTROL SET
K951135 · DIF
Microgenics Corp.
Chemistry · 31d
Cleared Apr 11, 1995
VIVAPORE 10
K943965 · JJH
Vivascience, Inc.
Chemistry · 257d
Cleared Apr 11, 1995
VIVAPORE 2
K943966 · JJH
Vivascience, Inc.
Chemistry · 257d
Cleared Apr 11, 1995
DOCUMENT SERUM MULTIANALYTE CALIBRATION VERIFICATION TEST SET
K950469 · JJY
Casco Standards
Chemistry · 67d
Cleared Apr 11, 1995
STRATUS PROGESTERONE FLUOROMETRIC ENZYME IMMUNOASSAY
K950570 · JLS
Baxter Diagnostics, Inc.
Chemistry · 67d
Cleared Apr 05, 1995
CHEMILUMINESCENCE LH
K935319 · CEP
Nichols Institute Diagnostics
Chemistry · 532d
Cleared Apr 05, 1995
IRISPEC URINE CHEMISTRY CONTROL PART A AND B
K945913 · JJW
International Remote Imaging Systems
Chemistry · 124d
Cleared Apr 05, 1995
AVL OMNI ANALYZER
K945915 · JJC
Avl Scientific Corp.
Chemistry · 124d
Cleared Apr 05, 1995
OCTEIA IGF-1 KIT
K950510 · CFL
Immunodiagnostic Systems , Ltd.
Chemistry · 58d
Cleared Apr 03, 1995
AURAFLEX(R) ESTRADIOL
K946199 · CHP
Organon Teknika Corp.
Chemistry · 104d
Cleared Apr 03, 1995
IMMULITE(R) TBG
K950072 · JJX
Diagnostic Products Corp.
Chemistry · 84d
Cleared Mar 30, 1995
ACCUSCREEN 17-HYDROXYPROGESTERONE
K934178 · JLX
Neometrics, Inc.
Chemistry · 580d
Cleared Mar 30, 1995
CAPRA (CAPRAC-R) WIPETEST AND WELL COUNTER
K946387 · JJJ
Capintec, Inc.
Chemistry · 125d
Cleared Mar 30, 1995
REP CHOLESTEROL PROFILE CONTROL
K950590 · JJX
Helena Laboratories
Chemistry · 49d
Cleared Mar 30, 1995
CARDIO REP LD CONTROL - CAT NO. 3325
K950801 · JJT
Helena Laboratories
Chemistry · 37d
Cleared Mar 30, 1995
ALKO TONOMETERED SALINE CONTROL
K950902 · JJS
Alko Diagnostic Corp.
Chemistry · 30d
Cleared Mar 24, 1995
EMIT IIC CALIBRATORS
K935192 · DKB
Syva Co.
Chemistry · 514d