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
5497–5520 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Jul 28, 1994
ALKO FLUIDS PACKS FOR NOVA 8 ANALYZERS
K942549 · JIX
Alko Diagnostic Corp.
Chemistry · 58d
Cleared Jul 28, 1994
CEDIA T4 MAB ASSAY
K942575 · KLI
Microgenics Corp.
Chemistry · 58d
Cleared Jul 28, 1994
AVL COMPACT 2 PH/BLOOD GAS ANALYZER
K942616 · CHL
Avl Scientific Corp.
Chemistry · 56d
Cleared Jul 20, 1994
GLUTAMYL-TRANSFERASE, PROCEDURE NO. 419
K935984 · JQB
Sigma Diagnostics, Inc.
Chemistry · 218d
Cleared Jul 20, 1994
DNA TRIGLYCERIDE PROCEDURE
K941063 · JGY
Data Medical Associates, Inc.
Chemistry · 134d
Cleared Jul 20, 1994
ACS CARDIO-TROL CONTROL
K941115 · JJY
Analytical Control Systems, Inc.
Chemistry · 135d
Cleared Jul 20, 1994
DUPONT ACA PLUS IMMUNOASSAY SYSTEM FOLLICLE STIMULATING HORMONE
K941221 · CGJ
Dupont Medical Products
Chemistry · 128d
Cleared Jul 20, 1994
STANBIO ALT/GPT (LUQUI-UV) TEST SET
K941314 · CKA
Stanbio Laboratory
Chemistry · 124d
Cleared Jul 18, 1994
ABBOTT PRISM ANALYZER
K940289 · JJE
Abbott Mfg., Inc.
Chemistry · 138d
Cleared Jul 18, 1994
ACE CLINICAL CHEMISTRY SYSTEM
K941489 · DIS
Schiapparelli Biosystems, Inc.
Chemistry · 112d
Cleared Jul 14, 1994
STANBIO Y-GT (LIQUICOLOR) TEST SET
K941315 · JQB
Stanbio Laboratory
Chemistry · 118d
Cleared Jul 14, 1994
BIOMEK SL WITH BIOMEK SL INCUBATOR
K941498 · JQW
Beckman Analytical and Biotechnology...
Chemistry · 108d
Cleared Jul 13, 1994
DIGOXIN FPIA REAGENT SET AND CALIBRATOR SET
K940569 · KXT
Sigma Diagnostics, Inc.
Chemistry · 155d
Cleared Jul 13, 1994
THEOPHYLLINE FPIA REAGENT SET AND CALIBRATORS
K942192 · LER
Sigma Diagnostics, Inc.
Chemistry · 70d
Cleared Jul 06, 1994
DSL IGFBP-3 RIA (DSL 6700)
K930047 · CFL
Diagnostic Systems Laboratories, Inc.
Chemistry · 547d
Cleared Jul 06, 1994
BECKMAN PANCREATIC AMYLASE (PAMY) REAGENT
K934293 · JFJ
Beckman-Diagnostic Systems Group
Chemistry · 307d
Cleared Jul 06, 1994
DOA LIQUID DRUGS OF ABUSE CONTROLS
K934498 · DIF
Medical Analysis Systems, Inc.
Chemistry · 294d
Cleared Jul 06, 1994
PREGNANCY CHECK
K941355 · LCX
Sa Scientific, Inc.
Chemistry · 107d
Cleared Jul 06, 1994
CREATINE KINASE METHOD
K941584 · JHS
Dupont Medical Products
Chemistry · 96d
Cleared Jul 06, 1994
BODYWISE PREGNANCEY TEST
K941771 · LCX
Charlton Assoc.
Chemistry · 86d
Cleared Jun 21, 1994
AXSYM(TM) T-UPTAKE
K934312 · KHQ
Abbott Laboratories
Chemistry · 293d
Cleared Jun 21, 1994
AXSYM(TM) TOTAL T4
K934384 · CDX
Abbott Laboratories
Chemistry · 293d
Cleared Jun 21, 1994
AXSYM ULTRASENSITIVE HTSH
K934410 · JLW
Abbott Laboratories
Chemistry · 284d
Cleared Jun 21, 1994
AXSYM FREE THYROXINE ( FREE T4 )
K934544 · CEC
Abbott Laboratories
Chemistry · 272d