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
4273–4296 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Jan 09, 1998
RANDOX INORGANIC PHOSPHOROUS
K974605 · CEO
Randox Laboratories, Ltd.
Chemistry · 30d
Cleared Jan 08, 1998
TRIAGE(R) CARDIAC PANEL CALIBRATION VERIFICATION CONTROLS, TRIAG (R)...
K974827 · JJY
Biosite Incorporated
Chemistry · 15d
Cleared Jan 07, 1998
TRACE REAGENT LINE FOR THE COBAS MIRA
K973869 · CKA
Trace America, Inc.
Chemistry · 105d
Cleared Jan 06, 1998
RANDOX IRON
K974604 · JMO
Randox Laboratories, Ltd.
Chemistry · 27d
Cleared Jan 06, 1998
REP CHOLESTEROL PROFILE CONTROL-II
K974609 · JJX
Helena Laboratories
Chemistry · 27d
Cleared Jan 02, 1998
GLUCOCHEK POCKETLAB II BLOOD GLUCOSE SYSTEM
K971653 · CGA
Clinical Diagnostics, Inc.
Chemistry · 241d
Cleared Jan 02, 1998
SPIFE IFE-6
K973040 · CFF
Helena Laboratories
Chemistry · 141d
Cleared Jan 02, 1998
AIMSTICK PBD PREGNANCY
K974368 · DHA
Germaine Laboratories, Inc.
Chemistry · 43d
Cleared Jan 02, 1998
SAFE NEEDLE DIRECT BLOOD TRANSFER DEVICE, MODEL TA-STV
K974374 · JKA
Ohmeda Medical
Chemistry · 43d
Cleared Jan 02, 1998
AIMSTICK PBD COMBO PREGNANCY
K974512 · DHA
Germaine Laboratories, Inc.
Chemistry · 32d
Cleared Jan 02, 1998
AMMONIA-INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY (DST)
K974620 · JIF
Trace America, Inc.
Chemistry · 22d
Cleared Jan 02, 1998
IMMULITE FREE T3
K974634 · CDP
Diagnostic Products Corp.
Chemistry · 21d
Cleared Dec 24, 1997
OSOM HCG-URINE TEST MODEL 101
K974159 · JHI
Wyntek Diagnostics, Inc.
Chemistry · 71d
Cleared Dec 24, 1997
BIOSIGN HCG-ONE STEP PREGNANCY TEST, ACCUSIGN HCG-ONE STEP PREGNANCY TEST,...
K974425 · DHA
Princeton BioMeditech Corp.
Chemistry · 30d
Cleared Dec 23, 1997
SANGUI BIOTECH, INC. INTACT-PTH (PARATHYROID HORMONE) ELISA
K974306 · CEW
Sangui Biotech, Inc.
Chemistry · 36d
Cleared Dec 22, 1997
RDI HOMOGENEOUS HDL CHOLESTEROL TEST
K973988 · LBS
Reference Diagnostics, Inc.
Chemistry · 62d
Cleared Dec 22, 1997
SEALITE SCIENCES, INC. AQUALITE FREE T, ASSAY
K974551 · CEC
Sealite Sciences, Inc.
Chemistry · 18d
Cleared Dec 19, 1997
MIDSTREAM HOME REGNANCY TEST
K973825 · DHA
Germaine Laboratories, Inc.
Chemistry · 73d
Cleared Dec 19, 1997
SIGNAL PREGNANCY TEST KIT
K974021 · LCX
Sa Scientific, Inc.
Chemistry · 58d
Cleared Dec 19, 1997
QUICKVUE SEMI-Q HCG-COMBO
K974052 · JHI
Quidel Corp.
Chemistry · 53d
Cleared Dec 19, 1997
CHOICE ACCU-TEST PREGNANCY TEST KIT
K974154 · LCX
Sa Scientific, Inc.
Chemistry · 45d
Cleared Dec 19, 1997
MICROPROTEIN STANDARD KIT
K974290 · JIX
Verichem Laboratories, Inc.
Chemistry · 35d
Cleared Dec 18, 1997
COBAS INTEGRA HDL-CHOLESTEROL DIRECT
K973284 · CHH
Roche Diagnostic Systems, Inc.
Chemistry · 107d
Cleared Dec 17, 1997
LACTEST I
K971944 · KHP
Jwt, Inc.
Chemistry · 204d