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
4225–4248 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Feb 24, 1998
TESTOTERONE ELISA
K973900 · CDZ
Kmi Diagnostics, Inc.
Chemistry · 133d
Cleared Feb 24, 1998
AVL OPTI CRITICAL CARE ANALYZER
K974784 · CEM
Avl Scientific Corp.
Chemistry · 64d
Cleared Feb 24, 1998
SYNERMED CREATININE REAGENT KIT
K974909 · CGX
Synermed Intl., Inc.
Chemistry · 55d
Cleared Feb 13, 1998
EPISCREEN ORAL SPECIMEN COLLECTION DEVICE
K973395 · PJD
Epitope, Inc.
Chemistry · 176d
Cleared Feb 13, 1998
ABBOTT ALCYON(TM) 300 (WITHOUT ISE MODULE) AND 300I (WITH ISE MODULE) ANALYZER
K974779 · JJE
Abbott Laboratories
Chemistry · 53d
Cleared Feb 13, 1998
CK-NAC REAGENT
K974833 · CGS
Intersect Systems, Inc.
Chemistry · 51d
Cleared Feb 12, 1998
RANDOX MAGNESIUM
K974606 · JGJ
Randox Laboratories, Ltd.
Chemistry · 64d
Cleared Feb 12, 1998
ABBOTT AXSYM SYSTEM
K974651 · JJE
Abbott Laboratories
Chemistry · 66d
Cleared Feb 12, 1998
BILIRUBIN-SL (TOTAL) ASSAY
K974874 · CIG
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 45d
Cleared Feb 12, 1998
OXYHEMOGLOBIN CONTROL FOR CO-OXIMETRY
K980178 · JJY
Bionostics, Inc.
Chemistry · 23d
Cleared Feb 12, 1998
SAN DIEGO BIOTECH HCG PREGNANCY DIPSTICK TEST
K980205 · JHI
San Diego Biotech
Chemistry · 23d
Cleared Feb 12, 1998
ALKALINE PHOSPHATASE-SL ASSAY CATALOGUE NUMBER 309-10, 309-30
K980316 · CJE
Diagnostic Chemicals , Ltd.
Chemistry · 16d
Cleared Feb 09, 1998
BIO-RAD MICROPLATE 17-HYDROXYPROGESTERONE TEST
K973350 · JLX
Bio-Rad
Chemistry · 157d
Cleared Feb 09, 1998
ABL700 SERIES BLOOD GAS , CO-OXIMETRY, ELECTROLYTE & METABOLITE SYSTEM
K980130 · CHL
Radiometer America, Inc.
Chemistry · 26d
Cleared Feb 06, 1998
DIGENE DML 2000 MICROPLATE LUMINOMETER
K980120 · JJQ
Digene Corp.
Chemistry · 24d
Cleared Feb 05, 1998
EASYBLOOD GAS ANALYZER
K974526 · CHL
Medica Corp.
Chemistry · 65d
Cleared Feb 05, 1998
VACUETTE (MULTI-USE HOLDER)
K974873 · JKA
Greiner Meditech, Inc.
Chemistry · 38d
Cleared Feb 05, 1998
CARESIDE BUN
K980057 · CDQ
Exigent Diagnostics, Inc.
Chemistry · 30d
Cleared Feb 05, 1998
VACUTAINER BRAND PRONTO NEEDLES HOLDER
K980098 · JKA
Becton Dickinson Vacutainer Systems
Chemistry · 24d
Cleared Feb 04, 1998
ALPHA 4 LS AUTOMATED MICROTITERPLATE PROCESSOR AND READER
K973938 · JJQ
Sfri, Inc.
Chemistry · 112d
Cleared Feb 04, 1998
ALPHA DX ANALYZER 01-0100, ALPHA DX MYO/CK/CK-MB/TNI CARDIAC PANEL TEST KIT...
K974839 · MMI
First Medical, Inc.
Chemistry · 42d
Cleared Feb 04, 1998
AMYLASE
K980013 · CIJ
Ac Biochemicals, Inc.
Chemistry · 33d
Cleared Feb 04, 1998
CARESIDE ALBUMIN
K980041 · CIX
Exigent Diagnostics, Inc.
Chemistry · 29d
Cleared Feb 04, 1998
CARESIDE TOTAL PROTEIN
K980042 · CEK
Exigent Diagnostics, Inc.
Chemistry · 29d