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
10969–10992 of 13,224
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Jun 25, 1982
IEC CENTRA 4 CENTRIFUGE
K821756 · JQC
International Equipment Co.
Chemistry · 10d
Cleared Jun 24, 1982
AMES/GILFORD OPTIMATE CLIN. CHEM & THER
K821583 · JJF
Gilford Instrument Laboratories, Inc.
Chemistry · 27d
Cleared Jun 24, 1982
GAMMADAB [125] FSH RADIOIMMUNAY KIT
K821611 · CGJ
Clinical Assays, Inc.
Chemistry · 22d
Cleared Jun 24, 1982
AUTOPAK ESTRIOL TEST DELIVERY SYSTEM
K821678 · CGI
Micromedic Systems
Chemistry · 16d
Cleared Jun 24, 1982
T3 UPTAKE DIAGNOSTIC KIT
K821722 · KHQ
Diagnostic Reagents, Inc.
Chemistry · 14d
Cleared Jun 24, 1982
T3 DIAGNOSTIC KIT RIA
K821725 · CDP
Diagnostic Reagents, Inc.
Chemistry · 16d
Cleared Jun 24, 1982
EMIT ST URINE METHAGUALONE ASSAY
K821768 · KXS
Syva Co.
Chemistry · 9d
Cleared Jun 22, 1982
FLUORO-CEP
K821060
Zeus Scientific, Inc.
Chemistry · 68d
Cleared Jun 22, 1982
GAMMADAB[125]EGE RADIOIMMUNOASSAY IT
K821092 · DGC
Clinical Assays, Inc.
Chemistry · 64d
Cleared Jun 22, 1982
CALCITONIN RIA TEST KIT, DLS 1200
K821675 · JKR
Diagnostic Systems Laboratories, Inc.
Chemistry · 14d
Cleared Jun 22, 1982
TITAN GEL HIGH RESOLUTION SERUM PROTEIN
K821688 · JJN
Helena Laboratories
Chemistry · 14d
Cleared Jun 22, 1982
TDX NETILMICIN
K821698 · LCE
Abbott Laboratories
Chemistry · 14d
Cleared Jun 14, 1982
YSI #24 & 24M GLUCOSE ANALYZERS
K821192 · CGA
Yellow Springs Instrument Co., Inc.
Chemistry · 48d
Cleared Jun 14, 1982
DOWFLOW ALT-UV DETERMINATION
K821536 · CKA
The Dow Chemical Co.
Chemistry · 21d
Cleared Jun 14, 1982
(125I) HTSH RADIOIMMUNOASSAY KIT
K821620 · JLW
Yang Laboratories, Inc.
Chemistry · 12d
Cleared Jun 14, 1982
NOVA IV FLUIDS PACK & EXTERNAL STANDARDS
K821623 · JIX
Shaban Mfg. Co.
Chemistry · 12d
Cleared Jun 14, 1982
DOXEPIN TRI-CY TEST SET
K821652 · LFG
Wien Laboratories, Inc.
Chemistry · 11d
Cleared Jun 14, 1982
PROTRIPTYLINE TRI-CY TEST SET
K821653 · LFG
Wien Laboratories, Inc.
Chemistry · 11d
Cleared Jun 11, 1982
EMIT TIMER UNIT #100
K821531 · JQP
Syva Co.
Chemistry · 21d
Cleared Jun 11, 1982
TANDEM PROLACTIN KIT
K821545 · CFT
Hybritech, Inc.
Chemistry · 17d
Cleared Jun 11, 1982
PREG-KNOW
K821552 · JHJ
Immuno Pathology Labs
Chemistry · 17d
Cleared Jun 11, 1982
LANCER MSA BUN DIAG. KIT
K821562 · CDQ
Sherwood Medical Co.
Chemistry · 17d
Cleared Jun 10, 1982
TANDEM - HGH KIT
K821366 · CFL
Hybritech, Inc.
Chemistry · 31d
Cleared Jun 10, 1982
IL 1302 PH BLOOD GAS ANALYZER
K821483 · CHL
Instrumentation Laboratory CO
Chemistry · 23d