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
5233–5256 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Mar 24, 1995
LIFESCAN SURESTEP BLOOD GLUCOSE MONITORING SYSTEM
K942455 · CGA
Lifescan, Inc.
Chemistry · 305d
Cleared Mar 24, 1995
IN VITRO DIAGNOSTIC URINE REAGENT STRIPS SET
K942648 · JIL
Teco Diagnostics
Chemistry · 294d
Cleared Mar 24, 1995
OLYMPUS INORGANIC PHOSPHORUS REAGENT
K944768 · CEO
Olympus America, Inc.
Chemistry · 178d
Cleared Mar 23, 1995
IMX FOLATE
K943691 · CGN
Abbott Mfg., Inc.
Chemistry · 237d
Cleared Mar 23, 1995
IMMULITE C-PEPTIDE
K943767 · JKD
Diagnostic Products Corp.
Chemistry · 233d
Cleared Mar 23, 1995
QUICKPRO BLOOD GLUCOSE TESTING SYSTEM
K944195 · CGA
Medisense, Inc.
Chemistry · 206d
Cleared Mar 23, 1995
BIORESOURCE TECHNOLOGY LIQUICHEMTROL-NORMAL LIQUID HEMAN PROTEIN...
K944728 · JJY
Bioresource Technology, Inc.
Chemistry · 178d
Cleared Mar 23, 1995
PRECISION Q I D BLOOD GLUCOSE TEST STRIPS
K945887 · CGA
Medisense, Inc.
Chemistry · 112d
Cleared Mar 21, 1995
CHEM TRAK ACCUMETER
K943599 · CHH
Chemtrak, Inc.
Chemistry · 258d
Cleared Mar 21, 1995
LIQUID ASSAYED TUMOR MARKER CONTROL LEVEL 1, LEVEL 2, LEVEL 3
K944525 · JJY
Medical Analysis Systems, Inc.
Chemistry · 186d
Cleared Mar 21, 1995
AURAFLEX PROLACTIN 200 TEST PACK, CALIBRATOR PACK, DILVENT 1
K944698 · CFT
Organon Teknika Corp.
Chemistry · 179d
Cleared Mar 21, 1995
URISTRIP REAGENT STRIPS TEST FOR PROTEIN, GLUCOSE, PH AND BLOOD
K946116 · JIL
Chemtech Labs, Inc.
Chemistry · 96d
Cleared Mar 21, 1995
ELX800 AND EL800 AUTOMATED MICROPLATE READERS
K950104 · JJQ
Bio-Tek Instruments, Inc.
Chemistry · 69d
Cleared Mar 21, 1995
MULTIPLE (IZON BLOOD & URINE COLLECTION KIT)
K950221 · JXA
Izon Business Products, Inc.
Chemistry · 61d
Cleared Mar 21, 1995
MULTIPLE (IZON URINE COLLECTION KIT)
K950246 · JXA
Izon Business Products, Inc.
Chemistry · 60d
Cleared Mar 20, 1995
CARBON DIOXIDE (C02)
K942735 · KHS
Teco Diagnostics
Chemistry · 283d
Cleared Mar 20, 1995
AURAFLEX HCG
K945331 · DHA
Organon Teknika Corp.
Chemistry · 139d
Cleared Mar 20, 1995
KENLOR HUMAN SPINAL FLUID CONTROL
K950326 · JJY
Kenlor Industries, Inc.
Chemistry · 61d
Cleared Mar 20, 1995
CLP HIGH LEVEL HIGH DENSITY LIPO PROTEIN CHOLESTEROL CONTROL-HL
K950589 · JJX
Creative Laboratory Products, Inc.
Chemistry · 39d
Cleared Mar 15, 1995
DIRECT LDL CHOLESTEROL IMMUNOSEPARATION REAGENT KIT
K943150 · MRR
Genzyme Corp.
Chemistry · 258d
Cleared Mar 15, 1995
OLYMPUS GLUCOSE REAGENT
K944406 · CFR
Olympus America, Inc.
Chemistry · 188d
Cleared Mar 13, 1995
SERUM @-HYDROXYBUTYRATE DEHYDROGENASE (HBDH)
K941427 · JMK
Teco Diagnostics
Chemistry · 354d
Cleared Mar 13, 1995
PRECISION-MULTI-SERA - HUMAN - NORMAL AND ELEVATED
K942458 · JJY
Randox Laboratories, Ltd.
Chemistry · 293d
Cleared Mar 13, 1995
PICCOLO(TM)
K942782 · JJG
Abaxis, Inc.
Chemistry · 273d