FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,218 clearances · 1976 to present · Updated monthly from FDA records

Filters: Chemistry ×
13,224 results
11233–11256 of 13,224
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Dec 03, 1981
SERUM IRON REAGENT SET
K812840 · JIY
Anco Medical Reagents & Assoc.
Chemistry · 55d
Cleared Dec 03, 1981
LIQUIZYME GLUCOSE REAGENT
K813168 · CGA
American Research Products Co.
Chemistry · 17d
Cleared Dec 03, 1981
PHENYLALANINE UV KINETIC TEST KIT
K813171 · JNB
Biochemicals, Inc.
Chemistry · 17d
Cleared Dec 03, 1981
C-TERMINAL PTH RIA TEST KIT, DSL-1000
K813203 · CEW
Diagnostic Systems Laboratories, Inc.
Chemistry · 20d
Cleared Nov 27, 1981
TOTAL PROTEIN REAGENT SET
K812833 · CEK
Anco Medical Reagents & Assoc.
Chemistry · 49d
Cleared Nov 27, 1981
TOTAL & DIRECT BILIRUBIN REAGENT SET
K812841 · CIG
Anco Medical Reagents & Assoc.
Chemistry · 49d
Cleared Nov 27, 1981
SYVA ADVANCE TM FLUOROMETER
K813146 · KHO
Syva Co.
Chemistry · 21d
Cleared Nov 27, 1981
HDL-C EIKEN
K813192 · LBS
Syn-Kit, Inc.
Chemistry · 10d
Cleared Nov 24, 1981
VITAMIN B12/FOLATE DUAL RADIOASSAY KITS
K812979 · CGN
Amersham Corp.
Chemistry · 32d
Cleared Nov 24, 1981
POLI-MAK II
K813102 · JJE
Pm America, Inc.
Chemistry · 21d
Cleared Nov 24, 1981
S/P VORTEX MIXER
K813148 · JRQ
American Dade
Chemistry · 18d
Cleared Nov 24, 1981
S/P VORTEX MIXER JR.
K813149 · JRQ
American Dade
Chemistry · 18d
Cleared Nov 24, 1981
ORTHO UNASSAYED CONTROL SERUM LEVEL II
K813167 · JJY
Ortho Diagnostic Systems, Inc.
Chemistry · 12d
Cleared Nov 16, 1981
LEECO TESTO-QUANT DIAG. KIT
K813059 · CDZ
Leeco Diagnostics, Inc.
Chemistry · 17d
Cleared Nov 16, 1981
PHOSPHOTUNGSTATE REDUCTION, URIC ACID
K813076 · CDH
American Monitor Corp.
Chemistry · 14d
Cleared Nov 16, 1981
TECHNICON RA 1000 SYSTEM
K813077 · JJC
Technicon Corp.
Chemistry · 14d
Cleared Nov 10, 1981
LORENZ BLOOD GAS ANALYZER
K812090 · CHL
Lorenz Instruments
Chemistry · 79d
Cleared Nov 10, 1981
QUANTUMATIC DUAL-WAVELENGTH SPECTRO
K812865 · JJQ
Abbott Laboratories
Chemistry · 28d
Cleared Nov 10, 1981
DSD
K812983 · JQW
Pm America, Inc.
Chemistry · 15d
Cleared Nov 10, 1981
ULTRACHEM TP, ITEM #64974
K813038 · CEK
Harleco
Chemistry · 13d
Cleared Nov 10, 1981
ULTRACHEM E-CHOL, ITEM #65025
K813039 · CHH
Harleco
Chemistry · 13d
Cleared Nov 10, 1981
ULTRACHEM CA, ITEM #64975
K813040 · CJY
Harleco
Chemistry · 13d
Cleared Nov 10, 1981
ULTRAZYME-GT, ITEM #64959 & 65032
K813041 · JQB
Harleco
Chemistry · 13d
Cleared Nov 10, 1981
ULTRACHEM GLUC-DH SET, ITEM #65048
K813042 · LFR
Harleco
Chemistry · 13d