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
6745–6768 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Nov 01, 1990
CLINICAL BLOOD GAS MIXTURES
K904163 · LCH
Norco, Inc.
Chemistry · 51d
Cleared Oct 29, 1990
'TDXFLX ANALYZER
K904226 · LCQ
Abbott Laboratories
Chemistry · 46d
Cleared Oct 26, 1990
EZ-BEAD TSH ENZYME IMMUNOASSAY KIT
K903725 · JLW
Immunotech Corp.
Chemistry · 71d
Cleared Oct 26, 1990
URIC ACID/IRON/MAGNESIUM LINEARITY STANDARDS
K904099 · JJY
Hichem Diagnostics
Chemistry · 50d
Cleared Oct 26, 1990
BIOCLONES ELEGANCE FSH ELISA KIT
K904405 · CGJ
Bioclone Australia Pty , Ltd.
Chemistry · 31d
Cleared Oct 26, 1990
METER TRAX
K904461 · JPK
Hematronix, Inc.
Chemistry · 25d
Cleared Oct 22, 1990
SEROTONIN ENZYME IMMUNOASSAY
K903609 · CDA
Immunotech Corp.
Chemistry · 74d
Cleared Oct 22, 1990
TARGET(TM) HOG ONE STEP
K903937 · JHI
V-Tech, Inc.
Chemistry · 56d
Cleared Oct 22, 1990
SYNCHRON CX 7 CLINICAL ANALYZER
K904219 · JJE
Beckman
Chemistry · 40d
Cleared Oct 22, 1990
ACCU-CHEK(R) III BLOOD GLUCOSE SYSTEM
K904292 · CGA
Boehringer Mannheim Corp.
Chemistry · 33d
Cleared Oct 15, 1990
QUICK CHECK 3 FILM
K903191 · CGA
Quantai Biotronics, Inc.
Chemistry · 88d
Cleared Oct 15, 1990
BIOMEK AUTOMATED LABORATORY WORKSTATION W/GENELISA
K903626 · JJG
Beckman Instruments, Inc.
Chemistry · 66d
Cleared Oct 15, 1990
MAXI TEST
K904016 · JHI
Bhc Biotech , Ltd.
Chemistry · 41d
Cleared Oct 15, 1990
DSL SEX HORMONE BINDING GLOBULIN (SHBG) (DSL 6300)
K904100 · CDZ
Diagnostic Systems Laboratories, Inc.
Chemistry · 39d
Cleared Oct 15, 1990
ACCU-CHEK (R) EASY (TM) BLOOD GLUCOSE SYSTEM
K904168 · CGA
Boehringer Mannheim Corp.
Chemistry · 34d
Cleared Oct 15, 1990
SYNCHRON CX4-CE
K904220 · JJE
Beckman
Chemistry · 33d
Cleared Oct 12, 1990
MILENIA (TM) LH
K902786 · CEP
Diagnostic Products Corp.
Chemistry · 108d
Cleared Oct 12, 1990
ROCHE COBAS READY GGT REAGENT
K903304 · JPZ
Roche Diagnostic Systems, Inc.
Chemistry · 80d
Cleared Oct 12, 1990
ALLEGRO LITE THYROID STIMULATING HORMONE CHEM. IMM
K903391 · JLW
Nichols Institute
Chemistry · 77d
Cleared Oct 12, 1990
IL T UPTAKE ASSAY SYSTEM
K903396 · KHQ
Instrumentation Laboratory CO
Chemistry · 77d
Cleared Oct 12, 1990
TDX FREE T3 CALCULATION
K903433 · CDP
Abbott Laboratories
Chemistry · 73d
Cleared Oct 12, 1990
SYNERMED ALBUMIN REAGENT KIT
K903543 · CIX
Synermed, Inc.
Chemistry · 66d
Cleared Oct 12, 1990
SYNERMED LDH REAGENT KIT
K903773 · CFJ
Synermed, Inc.
Chemistry · 53d
Cleared Oct 12, 1990
ROCHE COBAS READY RENAL PROFILE REAGENT STRIP
K904049 · JGZ
Roche Diagnostic Systems, Inc.
Chemistry · 38d