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
10873–10896 of 13,224
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Aug 25, 1982
DISPOSABLE DISPENSING-SPREAD PIPETS
K822292 · LIB
American Dade
Chemistry · 23d
Cleared Aug 24, 1982
CO2/CI STANDARDS
K822289 · JIX
Gilford Diagnostics
Chemistry · 22d
Cleared Aug 24, 1982
IMMU-COUNT 404
K822293 · JJJ
Kemble Instruments, Inc.
Chemistry · 22d
Cleared Aug 24, 1982
PROCEDURE #430 & REAGENTS FOR ACETAMIN
K822313 · LDP
Sigma Chemical Co.
Chemistry · 21d
Cleared Aug 16, 1982
TITAN GEL SERUM CONTROL
K821982 · JJY
Helena Laboratories
Chemistry · 41d
Cleared Aug 16, 1982
TOTAL IGE DISCS
K822206 · DGC
Kallestad Laboratories, Inc.
Chemistry · 21d
Cleared Aug 16, 1982
IMMO PHASE FSH RADIOIMMUNOASSAY
K822227 · CGJ
Corning Medical & Scientific
Chemistry · 20d
Cleared Aug 16, 1982
ACA URINARY PROTEIN CALIBRATOR
K822232 · JIS
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 20d
Cleared Aug 16, 1982
UREA NITROGEN REAGENT SET (MOD. BERTHEL
K822237 · CDL
Sterling Biochemical, Inc.
Chemistry · 19d
Cleared Aug 16, 1982
C-REACTIVE PROTEIN TEST KIT
K822332 · JIS
Sclavo, Inc.
Chemistry · 12d
Cleared Aug 12, 1982
GILCHEM Y-GT REAGENT
K822149 · JPZ
Gilford Diagnostics
Chemistry · 21d
Cleared Aug 10, 1982
BI-LEVEL ASSAYED TUMOR MARKER & ANTIN
K821026 · JJY
Ortho Diagnostic Systems, Inc.
Chemistry · 119d
Cleared Aug 05, 1982
ACRO PACK
K822121 · JRL
Gelman Sciences, Inc.
Chemistry · 17d
Cleared Aug 05, 1982
DADE CHILL TRAY
K822132 · JRR
American Dade
Chemistry · 16d
Cleared Aug 05, 1982
IMMUCHEM COVALENT-COAT
K822140 · JKC
Immuchem Corp.
Chemistry · 16d
Cleared Aug 05, 1982
CORNING 101 PRINTER
K822146 · JQP
Corning Medical & Scientific
Chemistry · 15d
Cleared Aug 05, 1982
UREA NITROGEN (ENZYMATIC) DETERMINATION
K822154 · CDN
The Dow Chemical Co.
Chemistry · 13d
Cleared Aug 03, 1982
IMMUNO DIAGNOSTICS ASSAY
K822026 · CZP
Helena Laboratories
Chemistry · 22d
Cleared Aug 03, 1982
IGE/THE OPHYLLINE CONTROL SERUM I,II,III
K822133 · JJY
Kallestad Laboratories, Inc.
Chemistry · 14d
Cleared Jul 27, 1982
ZETAPHASE-DIG
K822053 · DON
Biological & Diagnostic Products
Chemistry · 14d
Cleared Jul 27, 1982
EMIT C-REACTIVE PROTEIN AUTOCAROUSEL
K822067 · DCK
Syva Co.
Chemistry · 13d
Cleared Jul 27, 1982
DADE DISP. DISPENSING-SPREADING PIPETS
K822078 · JRC
American Dade
Chemistry · 12d
Cleared Jul 27, 1982
ENZYMATIC CO2
K822079 · KHS
American Monitor Corp.
Chemistry · 12d
Cleared Jul 23, 1982
THERMOFONTE AIR MESSAGE BATH
K821809 · ILJ
Greenfields
Chemistry · 35d