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
8545–8568 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Feb 04, 1987
ASTRA SYSTEMS MULTIPLE CHEMISTRY MODULE
K864522 · LBS
Beckman Instruments, Inc.
Chemistry · 79d
Cleared Feb 04, 1987
ADX(TM) ANALYZER
K864566 · JJQ
Abbott Laboratories
Chemistry · 77d
Cleared Feb 04, 1987
HCG SOLID PHASE COMPONENT SYSTEM
K864591 · JHI
Bd Becton Dickinson Vacutainer...
Chemistry · 75d
Cleared Feb 04, 1987
BIO-MEGA DIAGNOSTIC COATED TUBE IRMA TSH
K864659 · JLW
Bio Mega Diagnostic, Inc.
Chemistry · 68d
Cleared Feb 04, 1987
UNIFAST CALCIUM TEST
K864661 · CIC
Sclavo, Inc.
Chemistry · 68d
Cleared Feb 04, 1987
TSH MAB IRMA
K864839 · JLW
Bd Becton Dickinson Vacutainer...
Chemistry · 57d
Cleared Feb 02, 1987
DIGOXIN/RIA KIT COATED TUBE RADIOIMMUNOASSAY KIT
K864449 · DPO
Canadian Bioclinical, Ltd.
Chemistry · 82d
Cleared Feb 02, 1987
DELFIA(TM) TRIIODOTHYRONINE (T3) KIT
K864452 · CDP
Lkb Instruments, Inc.
Chemistry · 82d
Cleared Feb 02, 1987
ALFERR TIBC TUBE
K864548 · JQE
Benchmark Reagents
Chemistry · 75d
Cleared Jan 21, 1987
AMYLASE REAGENT
K864356 · CIJ
Trace Scientific , Ltd.
Chemistry · 79d
Cleared Jan 21, 1987
BECKMAN EPSILON(TM) PROLACTIN TEST KIT
K864439 · CFT
Beckman Instruments, Inc.
Chemistry · 70d
Cleared Jan 21, 1987
PSI AMYLASE REAGENT
K864464 · JFJ
Pointe Scientific, Inc.,
Chemistry · 70d
Cleared Jan 21, 1987
FERROZINE (COLORIMETRIC) IRON BINDING CAPACITY
K864882 · JIY
Pointe Scientific, Inc.,
Chemistry · 40d
Cleared Jan 21, 1987
AMRESCO FLOW PAC POTASSIUM REAGENT SET, #1460
K870033 · CEM
American Research Products Co.
Chemistry · 16d
Cleared Jan 14, 1987
PANTEX FTE FREE TESTOSTERONE RADIOIMMUNOASSAY KIT
K862483 · CDZ
Pantex, Div. Bio-Analysis, Inc.
Chemistry · 198d
Cleared Jan 14, 1987
CARDS(TM) - EARLY PREGNANCY TEST
K863341 · LCX
Pacific Biotech, Inc.
Chemistry · 139d
Cleared Jan 14, 1987
BAYER HEALTHCARE RAPIDQC PLUS
K870036 · JJS
Ciba Corning Diagnostics Corp.
Chemistry · 9d
Cleared Jan 13, 1987
CHEMTROL(TM)
K862565 · JJY
G.B.F. Industries, Inc.
Chemistry · 190d
Cleared Jan 13, 1987
AST S.C.E. (GOT)
K863054 · CIT
J. D. Assoc.
Chemistry · 154d
Cleared Jan 13, 1987
PEG 6,000
K863103 · CHH
J. D. Assoc.
Chemistry · 153d
Cleared Jan 13, 1987
LAD MODEL 535 LUMINOMETER
K864201 · JJQ
Los Alamos Diagnostics
Chemistry · 78d
Cleared Jan 13, 1987
UREA NITROGEN(BUN), COLORIMETRIC METHOD
K864742 · CDL
Tech-Co, Inc.
Chemistry · 40d
Cleared Jan 13, 1987
BIURET (COLORIMETRIC), TOTAL PROTEIN
K864743 · CEK
Tech-Co, Inc.
Chemistry · 40d
Cleared Jan 13, 1987
CREATINE PHOSPHOKINASE (CK)
K864744 · CGS
Tech-Co, Inc.
Chemistry · 40d