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
5041–5064 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Oct 20, 1995
PH-DETECT TEST
K952178 · JQY
Diagnostic Reagents, Inc.
Chemistry · 164d
Cleared Oct 20, 1995
ACCESS PROLACTIN ASSAY (MODIFICATION)
K954680 · CFT
Bio-Rad Laboratories, Inc.
Chemistry · 18d
Cleared Oct 19, 1995
ELX800UV
K953572 · JJQ
Bio-Tek Instruments, Inc.
Chemistry · 80d
Cleared Oct 19, 1995
BUHLMANN ANGIOSTENSIN II RIA
K954299 · CIB
Buhlmann Laboratories AG
Chemistry · 35d
Cleared Oct 17, 1995
EML105 ELECTROLYTE METABOLITE ANALYZER
K952621 · CGA
Radiometer America, Inc.
Chemistry · 131d
Cleared Oct 16, 1995
CARDS Q.S. HCG OR CONCISE PERFORMANCE PLUS HCG
K954273 · JHI
Quidel Corp.
Chemistry · 33d
Cleared Oct 13, 1995
TRACE COBAS MIRA RANGE
K952488 · CIX
Trace Scientific , Ltd.
Chemistry · 136d
Cleared Oct 13, 1995
STC DIAGNOSTICS AUTO-LYTE CREATININE ASSAY
K954266 · CGX
Solarcare Technologies Corp,Inc.
Chemistry · 31d
Cleared Oct 13, 1995
CAMEO HOME PREGNANCY TEST
K954364 · LCX
Quidel Corp.
Chemistry · 25d
Cleared Oct 07, 1995
AALTO SCIENTIFIC LIQUID CARDIAC CONTROL
K954074 · JJY
Aalto Scientific, Ltd.
Chemistry · 38d
Cleared Oct 07, 1995
ACTIVE THYROXINE RIA
K954312 · CDX
Diagnostic Systems Laboratories, Inc.
Chemistry · 22d
Cleared Oct 06, 1995
TOX PERFECT A TUBE
K953393 · DMP
Chimera Research & Chemical, Inc.
Chemistry · 84d
Cleared Oct 06, 1995
OPUS HCG CONTROLS
K954144 · JJX
Behring Diagnostics, Inc.
Chemistry · 31d
Cleared Oct 05, 1995
WAKO AUTOKIT GLUCOSE
K950172 · CGA
Wako Chemicals USA, Inc.
Chemistry · 261d
Cleared Oct 05, 1995
CARBON DIOXIDE - DST
K952410 · KHS
Trace America, Inc.
Chemistry · 134d
Cleared Oct 05, 1995
TESTPACK PLUS HCG URINE
K954029 · JHI
Abbott Laboratories
Chemistry · 38d
Cleared Oct 03, 1995
MINISTRIP HCG
K951705 · JHI
International Newtech Development, Inc.
Chemistry · 172d
Cleared Oct 03, 1995
DMA GLUCOSE HEXOKINASE U.V. PROCEDURE
K952437 · CFR
Data Medical Associates, Inc.
Chemistry · 131d
Cleared Oct 03, 1995
FIRST RESPONSE OVULATION PREDICTOR TEST
K953581 · CEP
Armkel, LLC
Chemistry · 63d
Cleared Oct 03, 1995
ABBOTT IMX PROLACTIN(MODIFICATION)
K953656 · CFT
Abbott Mfg., Inc.
Chemistry · 77d
Cleared Oct 03, 1995
APOLIPOPROTEIN CALIBRATOR (APO-CAL)
K953979 · JIX
Beckman Instruments, Inc.
Chemistry · 41d
Cleared Oct 02, 1995
ULTRA-SENSITIVE ESTRADIOL
K953605 · CHP
Diagnostic Systems Laboratories, Inc.
Chemistry · 61d
Cleared Sep 29, 1995
ASPARTATE AMINOTRANSFERASE REAGENT SYSTEM
K952743 · CIT
Medical Diagnostic Technologies, Inc.
Chemistry · 105d
Cleared Sep 28, 1995
BILI-METER
K953005 · JJQ
Olympic Medical Corp.
Chemistry · 92d