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
7873–7896 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared May 27, 1988
IMMUCHEM HUMAN CHORIONIC GONADOTROPIN HORMONE HCG
K881005 · JHI
Icn Biomedicals, Inc.
Chemistry · 79d
Cleared May 27, 1988
AUTO TROL(TM) CONTROL, LEVELS 1 & 2 #16692 & 16693
K881229 · JJY
Em Diagnostic Systems, Inc.
Chemistry · 66d
Cleared May 27, 1988
TOTAL BILIRUBIN REAGENT
K881241 · CIG
Tech-Neal Scientific, Inc.
Chemistry · 66d
Cleared May 27, 1988
HDL CHOLESTEROL PRECIPITATING PROCEDURE
K881326 · LBR
Data Medical Associates, Inc.
Chemistry · 59d
Cleared May 27, 1988
EMIT CONVENIENCE PACK: THYROXINE ASSAY
K881357 · KLI
Syva Co.
Chemistry · 57d
Cleared May 27, 1988
AMERLITE TT3 ASSAY, LAN.0003/2003 240/144 KIT
K881373 · CDP
Amersham Corp.
Chemistry · 56d
Cleared May 27, 1988
PREGNOSPIA II
K881435 · JHJ
Organon Teknika Corp.
Chemistry · 52d
Cleared May 27, 1988
IQ POTASSIUM
K881440 · CEJ
Bd Becton Dickinson Vacutainer...
Chemistry · 52d
Cleared May 27, 1988
LUMATAG(TM) TSH CHEMILUMINESCENCE IMMUNO. ASSAY
K881443 · JLW
London Diagnostics, Inc.
Chemistry · 52d
Cleared May 27, 1988
QUIDEL PREGNANCY TEST
K881595 · JHI
Quidel Corp.
Chemistry · 45d
Cleared May 27, 1988
FSH ENZYME IMMUNOASSAY TEST KIT NO. MB-1057
K881596 · CGJ
Medix Biotech, Inc.
Chemistry · 45d
Cleared May 27, 1988
GAMMA-GLUTAMYL TRANSFERASE
K881626 · JQB
Tech-Co, Inc.
Chemistry · 45d
Cleared May 27, 1988
SPECTRUM(TM) BLOOD GAS AND ELECTROLYTE CONTROL
K881655 · JJR
Biomedical Research & Development...
Chemistry · 42d
Cleared May 27, 1988
BIOTROL TRIGLYCERIDES ENZYMATIQUE UV H.P.
K881702 · CDT
Biotrol, USA, Inc.
Chemistry · 38d
Cleared May 17, 1988
PREGNANCY (HCG) CARD & LIQUID TEST
K880163 · JHJ
Ampcor, Inc.
Chemistry · 125d
Cleared May 17, 1988
MAGNESIUM LIQUID STABLE REAGENT SET
K881300 · JGJ
Medical Analysis Systems, Inc.
Chemistry · 50d
Cleared May 16, 1988
ADVANCE* AND DAISY* PREGNANCY TEST
K880472 · LCX
Advanced Care Products
Chemistry · 102d
Cleared May 16, 1988
HR VACUTRAC
K881201 · JKA
Icu Medical, Inc.
Chemistry · 56d
Cleared May 16, 1988
NOVA 12 NA/K/C1/TOTAL CARBON DIOXIDE/GLUCOSE/UREA
K881255 · JGS
Nova Biomedical Corp.
Chemistry · 54d
Cleared May 16, 1988
BIOTROL CK MONOEACTIF
K881267 · JHX
Biotrol, USA, Inc.
Chemistry · 53d
Cleared May 16, 1988
URIQUAL(TM) URINALYSIS CONTROLS (HUMAN) I & II
K881275 · JJY
Fisher Scientific Co., LLC
Chemistry · 52d
Cleared May 16, 1988
BIOTROL BUN ENZYMATIQUE UV H.P.
K881366 · CDQ
Biotrol, USA, Inc.
Chemistry · 46d
Cleared Apr 28, 1988
GEM-STAT, GEM-PAK 2, GEM-CHECK, GEM-CRIT CHECK
K873577 · CHL
Diamond Sensor Systems
Chemistry · 238d
Cleared Apr 28, 1988
MICRO-BUMINTEST REAGENT TABLETS
K874909 · JIR
Miles Laboratories, Inc.
Chemistry · 149d