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
5449–5472 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Sep 20, 1994
GAMMA-BCT INTACT PTH
K942369 · CEW
Immunodiagnostic Systems , Ltd.
Chemistry · 125d
Cleared Sep 20, 1994
UC QIK 1-STEP HCG TEST
K942464 · JHI
Eucardio Laboratory, Inc.
Chemistry · 119d
Cleared Sep 20, 1994
EMIT 2000 DIGOXIN ASSAY/CALIBRATORS
K942619 · LFM
Syva Co.
Chemistry · 117d
Cleared Sep 20, 1994
THE YELLOW IRIS
K943463 · KQO
Intl. Remote Imaging Systems
Chemistry · 64d
Cleared Sep 20, 1994
CREATININE-PO REAGENT KIT
K943924 · CGX
Synermed, Inc.
Chemistry · 39d
Cleared Sep 14, 1994
INTERSECT SYSTEMS' NON-MERCURIC CHLORIDE REAGENT
K941807 · CHG
Intersect Systems, Inc.
Chemistry · 155d
Cleared Sep 14, 1994
BILIRUBIN PLUS/PEDIATRIC CONTROLS
K943290 · JJY
Medi-Tech, Inc.
Chemistry · 68d
Cleared Sep 14, 1994
OPERA SYSTEM
K943376 · JJC
Miles, Inc.
Chemistry · 63d
Cleared Sep 14, 1994
LIPASE CALIBRATOR
K943704 · JIT
The DU Pont Co.
Chemistry · 44d
Cleared Sep 14, 1994
BLOOD GADS, ELECTROLYTE, GLUCOSE, LATATE AND BUN QUALITY CONTROL PRODUCT
K943754 · JJY
Bionostics, Inc.
Chemistry · 43d
Cleared Sep 09, 1994
URINE REAGENT STRIP-3 PARAMETERS
K940469 · JIL
Teco Diagnostics
Chemistry · 219d
Cleared Sep 09, 1994
REP HDL/LDL-30 KIT - CAT. NO. 3220,3221,3222
K940679 · JHO
Helena Laboratories
Chemistry · 212d
Cleared Sep 09, 1994
DUPONT DIMENSION AMYLASE METHOD
K942640 · JFJ
Dupont Medical Products
Chemistry · 98d
Cleared Sep 09, 1994
AVL 988-4 ELECTROLYTE ANALYZER
K943702 · JFP
Avl Scientific Corp.
Chemistry · 42d
Cleared Sep 07, 1994
ACCESS(R) TOTAL T3
K940833 · CDP
Bio-Rad Laboratories, Inc.
Chemistry · 196d
Cleared Sep 07, 1994
CLINICAL ASSAYS GAMMACOAT [125] ESTRADIOL RADIOIMMUNOASSAY KIT
K941168 · CHP
Incstar Corp.
Chemistry · 177d
Cleared Sep 07, 1994
OCTEIA INTACT PTH
K941878 · CEW
I.D.S.
Chemistry · 142d
Cleared Sep 07, 1994
SIMULTRAC LH/FSH RADIOUMMUNOASSAY KIT
K942638 · CEP
Bd Becton Dickinson Vacutainer...
Chemistry · 96d
Cleared Sep 06, 1994
DELFIA SHBG KIT
K940449 · CDZ
Wallac OY
Chemistry · 217d
Cleared Sep 06, 1994
FLUIDS PACK FOR CORING 238
K940760 · JIX
Alko Diagnostic Corp.
Chemistry · 200d
Cleared Sep 06, 1994
PBI PLUS HDL PRECIPITATING REAGENT
K941744 · LBR
Merchant House Scientific
Chemistry · 152d
Cleared Sep 06, 1994
DMA MICROPROTEIN PROCEDURE
K942424 · CEK
Data Medical Associates, Inc.
Chemistry · 109d
Cleared Sep 02, 1994
ROCHE TDM CALIBRATION VERIFICATION TEST SET
K942114 · DIF
Roche Diagnostic Systems, Inc.
Chemistry · 122d
Cleared Sep 02, 1994
4 CHANNEL DISPENSER
K942655 · JQW
Tecan U.S., Inc.
Chemistry · 88d