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
5089–5112 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Sep 05, 1995
QUALICHECK 4 GLUCOSE
K952637 · JJS
Radiometer America, Inc.
Chemistry · 88d
Cleared Aug 31, 1995
DUPONT LIPASE CALIBRATOR
K952815 · JIT
Dupont Medical Products
Chemistry · 72d
Cleared Aug 31, 1995
SYNERMED CALCIUM REAGENT KIT
K953395 · CJY
Synermed, Inc.
Chemistry · 44d
Cleared Aug 29, 1995
WYNTEK OSOM HCG-URINE TEST
K953383 · JHI
Wyntek Diagnostics, Inc.
Chemistry · 41d
Cleared Aug 24, 1995
RADIAS NEONATAL T4 ENZYME IMMUNOASSAY
K951321 · KLI
Bio-Rad
Chemistry · 154d
Cleared Aug 24, 1995
ADVANTAGE TEST STRIPS
K951887 · LFR
Boehringer Mannheim Corp.
Chemistry · 122d
Cleared Aug 24, 1995
TOX PERFECT B TUBES AND REAGENTS
K952501 · DPM
Chimera Research & Chemical, Inc.
Chemistry · 86d
Cleared Aug 24, 1995
ALKPHASE-B ASSAY KIT
K952768 · CIN
Metra Biosystems, Inc.
Chemistry · 71d
Cleared Aug 24, 1995
CSF LIQUID CEREBROSPINAL FLUID CONTROL
K952877 · JJY
Medical Analysis Systems, Inc.
Chemistry · 62d
Cleared Aug 24, 1995
OPUS T4 CONTROLS
K953097 · JJX
Behring Diagnostics, Inc.
Chemistry · 52d
Cleared Aug 24, 1995
OPUS T3
K953160 · CDP
Behring Diagnostics, Inc.
Chemistry · 48d
Cleared Aug 23, 1995
DMA TOTAL CHOLESTEROL PROCEDURE
K946161 · CHH
Data Medical Associates, Inc.
Chemistry · 247d
Cleared Aug 23, 1995
CONCEIVE OVULATION PREDICTOR
K953063 · CEP
Quidel Corp.
Chemistry · 54d
Cleared Aug 23, 1995
OPUS B12
K953455 · CDD
Behring Diagnostics, Inc.
Chemistry · 35d
Cleared Aug 17, 1995
CX LIPASE REAGENT & CALIBRATOR FOR SYNCHRON CX SYSTEMS
K952180 · CHI
Beckman Instruments, Inc.
Chemistry · 100d
Cleared Aug 17, 1995
TRIGLYCERIDES (GLYCEROL BLANKING) REAGENT SYSTEM
K952741 · CDT
Medical Diagnostic Technologies, Inc.
Chemistry · 62d
Cleared Aug 11, 1995
DUPONT DIMENSION TOTAL PROTEIN METHOD
K950920 · CEK
Dupont Medical Products
Chemistry · 163d
Cleared Aug 11, 1995
ACCUSPORT LACTATE MONITORING SYSTEM LACTATE TEST STRIPS ACCUSPORT MONITOR
K951331 · KHP
Boehringer Mannheim Corp.
Chemistry · 140d
Cleared Aug 11, 1995
ALKALINE PHOSPHATASE (ALP/AMP) PROCEDURE NO. 247
K951584 · CJE
Sigma Diagnostics, Inc.
Chemistry · 127d
Cleared Aug 11, 1995
BLOOD UREA NITROGEN REAGENT SYSTEM
K952742 · CDQ
Medical Diagnostic Technologies, Inc.
Chemistry · 56d
Cleared Aug 11, 1995
CREATINE KINASE REAGENT SYSTEM
K952745 · CGS
Medical Diagnostic Technologies, Inc.
Chemistry · 56d
Cleared Aug 11, 1995
DIA SCREEN REAGENT STRIPS
K952971 · JIL
Genesis Labs, Inc.
Chemistry · 45d
Cleared Aug 07, 1995
MAGNESIUM REAGENT
K952426 · JGJ
Schiapparelli Biosystems, Inc.
Chemistry · 75d
Cleared Aug 07, 1995
ALANINE AMINOTRANSFERASE REAGENT SYSTEM
K952744 · CKA
Medical Diagnostic Technologies, Inc.
Chemistry · 52d