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
3409–3432 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Jul 31, 2001
CALIBRATOR FOR AUTOMATED SYSTEMS (C.F.A.S.) LIPIDS
K011658 · JIX
Rochdiag
Chemistry · 63d
Cleared Jul 30, 2001
OSTEOMARK NTX POINT OF CARE PRESCRIPTION HOME USE
K011052 · JMM
Ostex Intl., Inc.
Chemistry · 115d
Cleared Jul 30, 2001
BRANAN MEDICAL CORPERATION MONITECT TCA DRUG SCREEN TEST, MODEL MC21 AND MD21
K010734 · MLK
Branan Medical Corp.
Chemistry · 140d
Cleared Jul 25, 2001
HOMOGENEOUS ENZYMIC HOMOCYSTEINE REAGENT
K011692 · LPS
Intersect Systems, Inc.
Chemistry · 55d
Cleared Jul 25, 2001
HOMOGENEOUS ENZYMIC HOMOCYSTEINE REAGENT
K011689 · LPS
Catch, Inc.
Chemistry · 55d
Cleared Jul 25, 2001
LIPOPRINT SYSTEM, LDL SUBFRACTIONS
K010337 · JHO
Quantimetrix Corp.
Chemistry · 170d
Cleared Jul 20, 2001
ALKALINE PHOSPHATASE LIQUID REAGENT
K011599 · CJE
Jas Diagnostics, Inc.
Chemistry · 57d
Cleared Jul 20, 2001
BIOCHECK HIGH SENSITIVITY C-REACTIVE PROTEIN ENZYME IMMUNOASSAY TEST KIT,...
K003851 · DCK
Biocheck, Inc.
Chemistry · 220d
Cleared Jul 17, 2001
UREA NITROGEN (BUN) LIQUID REAGENT
K011596 · CDQ
Jas Diagnostic, Inc.
Chemistry · 54d
Cleared Jul 17, 2001
CYCLOSPORINE CALIBRATOR
K011112 · DLJ
Dade Behring, Inc.
Chemistry · 97d
Cleared Jul 16, 2001
SAFE AT HOME TSH (THYROID STIMULATING HORMONE BLOOD COLLECTION AND TRANSPORT...
K011525 · JLW
Biosafe Laboratories, Inc.
Chemistry · 60d
Cleared Jul 12, 2001
LIQUID ASSAYED MULTIQUAL CONTROL LEVEL1 #981600
K011867 · JJY
Bio-Rad
Chemistry · 28d
Cleared Jul 09, 2001
JAS CALCIUM (ARSENAZO) REAGENT
K011441 · CJY
Jas Diagnostics, Inc.
Chemistry · 60d
Cleared Jul 09, 2001
TGL FLEX REAGENT CARTRIDGE
K010871 · CDT
Dade Behring, Inc.
Chemistry · 108d
Cleared Jul 05, 2001
TRI-POINT LIQUIMMUNE LIQUID ASSAYED CONTROL LEVELS 1,2, AND 3
K011731 · JJY
Medical Analysis Systems, Inc.
Chemistry · 30d
Cleared Jul 02, 2001
IMMULITE INTACT PTH, MODEL LKPP1 (100 TESTS), LKPP5 (500 TESTS), IMMULITE...
K011505 · CEW
Diagnostic Products Corp.
Chemistry · 47d
Cleared Jul 02, 2001
I-STAT SYSTEM
K011478 · KHP
I-Stat Corp.
Chemistry · 49d
Cleared Jun 28, 2001
VACUETTE EVACUATED BLOOD COLLECTION TUBES
K011699 · JKA
Greiner Bio-One Vacuette North America
Chemistry · 27d
Cleared Jun 25, 2001
OLYMPUS AU5400 CLINICAL CHEMISTRY ANALYZER
K011720 · CIX
Olympus America, Inc.
Chemistry · 21d
Cleared Jun 25, 2001
CALIBRATOR FOR AUTOMATED SYSTEMS
K011226 · JIX
Roche Diagnostics Corp.
Chemistry · 66d
Cleared Jun 25, 2001
MODIFICATION TO REFLOTRON AMYLASE, CAT. 1200658
K011145 · JFJ
Roche Diagnostics Corp.
Chemistry · 91d
Cleared Jun 21, 2001
INDUO BLOOD GLUCOSE METER
K011616 · NBW
Inverness Medical Innovations, Inc.
Chemistry · 27d
Cleared Jun 20, 2001
ACCU-CHEK ACTIVE SYSTEM
K011738 · NBW
Roche Diagnostics Corp.
Chemistry · 15d
Cleared Jun 20, 2001
BIOSCANNER CREATININE TEST STRIPS
K010456 · JFY
Polymer Technology Systems, Inc.
Chemistry · 124d