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
3913–3936 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Feb 16, 1999
CK
K983070 · CGS
Abbott Laboratories
Chemistry · 167d
Cleared Feb 11, 1999
INFINITY GLUCOSE REAGENT
K984574 · CFR
Sigma Diagnostics, Inc.
Chemistry · 50d
Cleared Feb 08, 1999
CARESIDE AMYLASE
K990025 · JFJ
Careside, Inc.
Chemistry · 35d
Cleared Feb 05, 1999
NICHOLS ADVANTAGE CHEMILUMINESCENCE CORTISOL IMMUNOASSAY, MODEL 62-7005
K984520 · CGR
Nichols Institute Diagnostics
Chemistry · 46d
Cleared Feb 05, 1999
ABBOTT ARCHITECT FOLATE
K984301 · CGN
Abbott Laboratories
Chemistry · 65d
Cleared Feb 05, 1999
VITROS IMMUNODIAGNOSTIC PRODUCTS FOLATE REAGENT PACK 1/2, VITROS...
K984166 · CGN
Ortho-Clinical Diagnostics, Inc.
Chemistry · 77d
Cleared Feb 05, 1999
ACCU-CHEK HQ SYSTEM
K983047 · LFR
Boehringer Mannheim Corp.
Chemistry · 157d
Cleared Feb 03, 1999
ABBOTT ARCHITECT B12
K984108 · LIG
Abbott Laboratories
Chemistry · 78d
Cleared Feb 03, 1999
OPTICOAT T4 EIA KIT
K982298 · KLI
Biotecx Laboratories, Inc.
Chemistry · 217d
Cleared Feb 02, 1999
ARCHITECT FOLATE MASTERCHEK, MODEL # 6C12-05
K984625 · JJX
Bio-Rad
Chemistry · 36d
Cleared Feb 02, 1999
ARCHITECT ESTRADIOL MASTERCHEK, MODEL # 6C22-05
K984604 · JJX
Bio-Rad
Chemistry · 36d
Cleared Feb 02, 1999
LYPHOCHEK MATERNAL SERUM CONTROL, MODEL 220
K984594 · JJY
Bio-Rad
Chemistry · 36d
Cleared Feb 02, 1999
QUANTEX ASO-CRP-RP CONTROL II
K984437 · JJT
Instrumentation Laboratory CO
Chemistry · 50d
Cleared Feb 02, 1999
OSTEOMARK NTX SERUM EIA
K983457 · JMM
Ostex Intl., Inc.
Chemistry · 125d
Cleared Feb 02, 1999
WALLAC NEONATAL LEUCINE TEST KIT MODEL NL-1000
K982307 · JNB
Wallac, Inc.
Chemistry · 216d
Cleared Jan 29, 1999
AVL OMNI MODULAR ANALYZER
K990092 · CHL
Avl Scientific Corp.
Chemistry · 18d
Cleared Jan 29, 1999
ARCHITECT B12 MASTERCHEK, MODEL # 6C09-O5
K984626 · JJX
Bio-Rad
Chemistry · 32d
Cleared Jan 29, 1999
LYPHOCHEK WHOLE BLOOD METALS CONTROL LEVELS 1,2,3, MODELS 527, 528, 529
K984477 · JJY
Bio-Rad
Chemistry · 44d
Cleared Jan 29, 1999
SYNCHRON SYSTEMS AMMONIA (AMM) REAGENT
K984402 · JIF
Beckman Coulter, Inc.
Chemistry · 51d
Cleared Jan 29, 1999
VITROS IMMUNODIAGNOSTIC PRODUCTS: NTX CALIBRATORS, NTX REAGENT PACK, NTX...
K983674 · JMM
Ortho-Clinical Diagnostics, Inc.
Chemistry · 101d
Cleared Jan 29, 1999
BAYER ADVIA IMS SYSTEM (IN VITRO DIAGNOSTIC SYSTEM)
K982328 · CJO
Bayer Corp.
Chemistry · 211d
Cleared Jan 28, 1999
ABBOTT LIQUID AMMONIA CONTROL, MODEL #'S 1E93-01,1E94-01,1E95-01
K990162 · JJX
Bio-Rad
Chemistry · 9d
Cleared Jan 28, 1999
ABBOTT LIQUID CSF CONTROL, MODEL #'S 1E98-01, 1E99-01
K990161 · JJY
Bio-Rad
Chemistry · 9d
Cleared Jan 28, 1999
VITROS CHEMISTRY PRODUCTS MAGNETIC HDL-CHOLESTEROL REAGENT
K984303 · LBR
Ortho-Clinical Diagnostics, Inc.
Chemistry · 57d