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
3865–3888 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared May 04, 1999
SAS HCG-CHECK
K991193 · LCX
Sa Scientific, Inc.
Chemistry · 26d
Cleared Apr 29, 1999
IN TOUCH DIABETES MANAGEMENT SOFTWARE
K984527 · CGA
Lifescan, Inc.
Chemistry · 129d
Cleared Apr 28, 1999
QUICKCARD HCG COMBO TEST, MODEL #9014
K991095 · JHI
Phamatech
Chemistry · 27d
Cleared Apr 27, 1999
MODIFICATION TO IMMULITE MYOGLOBIN, MODEL LKMY1, LKMY5
K991277 · DDR
Diagnostic Products Corp.
Chemistry · 13d
Cleared Apr 27, 1999
MODIFICATION OF: DAVIDSTRIP HCG
K991067 · JHI
Simex Medical, Inc.
Chemistry · 28d
Cleared Apr 27, 1999
EASYLYTE QUALITY CONTROL KIT, MODELS 2814, 2815, 2816
K990971 · JJR
Medica Corp.
Chemistry · 35d
Cleared Apr 27, 1999
ABBOTT TUMOR MARKER-MCC (LYOPHILIZED), MODEL 6E21-10
K990610 · JJY
Bio-Rad
Chemistry · 62d
Cleared Apr 20, 1999
FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM
K990939 · CGA
Selfcare, Inc.
Chemistry · 29d
Cleared Apr 20, 1999
CARBON DIOXIDE - L3K ASSAY, CATALOGUE NUMBER 299-30/40/50
K990754 · KHS
Diagnostic Chemicals , Ltd.
Chemistry · 43d
Cleared Apr 19, 1999
CARESIDE CK
K990439 · JHS
Careside, Inc.
Chemistry · 67d
Cleared Apr 19, 1999
CARESIDE CKMB
K990434 · JHS
Careside, Inc.
Chemistry · 67d
Cleared Apr 14, 1999
INTEGRA REAGENT CASSETTE FOR APOLIPOPROTEIN B
K990595 · DFC
Roche Diagnostics Corp.
Chemistry · 49d
Cleared Apr 14, 1999
INTEGRA REAGENT CASSETTE FOR APOLIPOPROTEIN A-1
K990594 · DER
Roche Diagnostics Corp.
Chemistry · 49d
Cleared Apr 09, 1999
MICROPLATE NEONATAL GALT ASSAY
K990827 · KQP
Bio-Rad
Chemistry · 28d
Cleared Apr 07, 1999
MODIFICATION TO LIQUICHEK SPINAL FLUID CONTROL, ITEM NOS. 751, 752
K990888 · JJY
Bio-Rad
Chemistry · 28d
Cleared Apr 07, 1999
CLEARPLAN EASY HOME PREGNANCY TEST
K990262 · LCX
Unipath , Ltd.
Chemistry · 70d
Cleared Apr 02, 1999
SPQ TEST SYSTEM
K982708 · DFC
DiaSorin, Inc.
Chemistry · 241d
Cleared Mar 31, 1999
ABBOTT LIQUID IMMUNOLOGY CONTROL MODELS 2E01-01/2E02-01/2E03-01
K990424 · JJY
Bio-Rad
Chemistry · 48d
Cleared Mar 30, 1999
ARCHITECT CEA MASTERCHECK, MODEL 6CO2-05
K990608 · JJX
Bio-Rad
Chemistry · 34d
Cleared Mar 23, 1999
RANDOX ALBUMIN
K984494 · CIX
Randox Laboratories, Ltd.
Chemistry · 96d
Cleared Mar 22, 1999
CALIBRATOR FOR AUTOMATED SYSTEMS (C.F.A.S.)
K990460 · JIX
Roche Diagnostics Corp.
Chemistry · 38d
Cleared Mar 22, 1999
ARCHITECT PROGESTERONE MASTERCHECK MODEL #6C26-05
K990393 · JJX
Bio-Rad
Chemistry · 41d
Cleared Mar 22, 1999
OVUSTICK LH OVULATION PREDICTOR, MODEL 9030, OVUCARD LH OVULATION PREDICTOR,...
K990249 · CEP
Phamatech
Chemistry · 55d
Cleared Mar 19, 1999
SAS HCG URINE CONTROLS
K990755 · JJX
Sa Scientific, Inc.
Chemistry · 11d