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
11665–11688 of 13,224
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Jan 02, 1981
RIAPHASE (125I) PROST. ACID PHOSPH. KIT
K803043 · JFH
Beckman Instruments, Inc.
Chemistry · 32d
Cleared Jan 02, 1981
IMMU-TRACE T3 UPTAKE (T3U) REAGENTS
K803044 · KHQ
American Dade
Chemistry · 32d
Cleared Jan 02, 1981
IMMU-TRACE T4 RIA PROCEDURE
K803046 · CDX
American Dade
Chemistry · 32d
Cleared Jan 02, 1981
LANCER CREATININE MICROSAMPLE STAT ANA
K803087 · CGX
Sherwood Medical Co.
Chemistry · 25d
Cleared Jan 02, 1981
MAGNESIUM TEST KIT
K803088 · JGJ
Mallinckrodt Critical Care
Chemistry · 25d
Cleared Jan 02, 1981
GAMMA-GLUTAMYL TRANSPEPTIDASE (GGT)
K803089 · JPZ
Environmental Chemical Specialties
Chemistry · 25d
Cleared Dec 22, 1980
CHEM-ASSAY STANDARD-CONTROLS
K802962 · JJY
National Bio-Technical Laboratories
Chemistry · 31d
Cleared Dec 22, 1980
HDL-CHOLESTEROL CONTROL SERUM
K802997 · JJX
Isolab, Inc.
Chemistry · 27d
Cleared Dec 22, 1980
BETA-TEC QUALITATIVE
K802999 · JHI
Armkel, LLC
Chemistry · 27d
Cleared Dec 22, 1980
AMINO ACID ANALYSER SYSTEM
K803004 · JJF
Lkb Instruments, Inc.
Chemistry · 26d
Cleared Dec 22, 1980
SERALYZER LDH REAGENT STRIPS, CALIBR
K803019 · CFJ
Miles Laboratories, Inc.
Chemistry · 24d
Cleared Dec 22, 1980
FOLATE 125I RADIOIMMUNOASSAY
K803060 · CGN
Corning Medical & Scientific
Chemistry · 101d
Cleared Dec 22, 1980
AMES TDA AMIKACIN CONTROL SERUM
K803107 · LAS
Miles Laboratories, Inc.
Chemistry · 12d
Cleared Dec 19, 1980
AMIKACIN RIA KIT
K802877 · KLQ
Antibodies, Inc.
Chemistry · 32d
Cleared Dec 19, 1980
T3-SQUIBB RIA KIT
K802883 · CDP
E. R. Squibb & Sons, Inc.
Chemistry · 32d
Cleared Dec 19, 1980
BECKMAN ASTRA SYSTEMS CALCIUM CHEMISTRY
K802923 · CIC
Beckman Instruments, Inc.
Chemistry · 31d
Cleared Dec 19, 1980
NIKON URINE REFRACTOMER SG-1
K802959 · JRE
Nippon Kogaku, Inc.
Chemistry · 29d
Cleared Dec 19, 1980
RAPI-DOT
K802974 · JHJ
Organon, Inc.
Chemistry · 28d
Cleared Dec 18, 1980
SINGLE VIAL LIPASE TEST KIT
K802842 · CHI
Biodynamics Corp.
Chemistry · 36d
Cleared Dec 11, 1980
PARAGON ELECTROPHORESIS LACTATE REAG.KIT
K802628 · CFE
Beckman Instruments, Inc.
Chemistry · 49d
Cleared Dec 11, 1980
CREATININE STANDARDS
K802631 · JIS
Gilford Diagnostics
Chemistry · 49d
Cleared Dec 11, 1980
ALBUMIN/TOTAL PROTEIN STANDARDS
K802632 · JIX
Gilford Diagnostics
Chemistry · 49d
Cleared Dec 11, 1980
BUN/GLUCOSE STANDARDS
K802633 · JIX
Gilford Diagnostics
Chemistry · 49d
Cleared Dec 11, 1980
VISTA 54 LIQUID CHROMATOGRAPHY ANAL. SYS
K802725 · KZR
Varian Assoc., Inc.
Chemistry · 41d