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
7153–7176 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Dec 29, 1989
HUMAN GROWTH HORMONE ENZYME IMMUNOASSAY MB-1015
K896643 · CFL
Medix Biotech, Inc.
Chemistry · 35d
Cleared Dec 27, 1989
ACC.U.DIAL
K894423 · JJQ
Exocell, Inc.
Chemistry · 163d
Cleared Dec 27, 1989
CLINISTAT HDL CHOLESTEROL REAGENT TEST
K895139 · LBS
Heraeus Kulzer, Inc.
Chemistry · 133d
Cleared Dec 27, 1989
AMDEV LYTENING 2Z SODIUM/POTASSIUM/LITHIUM ANALYZE
K895465 · JIH
Baxter Healthcare Corp
Chemistry · 107d
Cleared Dec 27, 1989
BECKMAN MA MICROALBUMIN REAGENT KIT
K895883 · JIQ
Beckman Instruments, Inc.
Chemistry · 83d
Cleared Dec 27, 1989
NORMAL AND ABNORMAL CONTROL SERA
K895943 · JJY
Sclavo, Inc.
Chemistry · 77d
Cleared Dec 27, 1989
ESTRADIOL SEROZYME IMMUNOENZYMETRIC ASSAY
K896145 · CHP
Serono-Baker Diagnostics, Inc.
Chemistry · 65d
Cleared Dec 27, 1989
MODIFIED PROLACTIN ENZYME IMMUNOASSAY TEST KIT
K896641 · CFT
Medix Biotech, Inc.
Chemistry · 33d
Cleared Dec 27, 1989
MAGNET PAD
K896802 · LXG
Westmark, Sterile Packing Systems,...
Chemistry · 26d
Cleared Dec 22, 1989
MODIFIED HI CHEM AMYLASE REAGENT (PRODUCT #88129)
K895555 · CJA
Hichem Diagnostics
Chemistry · 107d
Cleared Dec 21, 1989
BICARBONATE FOR MANUAL/AUTOMATED APPLICATIONS
K895748 · KHS
Catachem, Inc.
Chemistry · 86d
Cleared Dec 19, 1989
SRI HUMAN CHORIONIC GONADOTROPIN IMMUNOENZ ASSAY
K894175 · JHI
Serono-Baker Diagnostics, Inc.
Chemistry · 187d
Cleared Dec 19, 1989
PANCREATIC A-AMYLASE EPS
K895880 · CIL
Boehringer Mannheim Corp.
Chemistry · 75d
Cleared Dec 19, 1989
COBAS READY
K896007 · JJQ
Roche Diagnostic Systems, Inc.
Chemistry · 67d
Cleared Dec 19, 1989
AUTOSCAN, AUTOSTRIP AND AUTOCONTROL
K896144 · CGA
Cascade Medical, Inc.
Chemistry · 57d
Cleared Dec 12, 1989
CALCIUM AND PH ELECTROLYTE ANALYZER
K895397 · JFP
Ionetics, Inc.
Chemistry · 102d
Cleared Dec 12, 1989
CALCIUM, CATALOGUE NUMBER140-20
K895873 · CJY
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 69d
Cleared Dec 12, 1989
EASYLYTE SODIUM/POTASSIUM/CHLORIDE ANALYZER
K895936 · JGS
Medica Corp.
Chemistry · 62d
Cleared Dec 12, 1989
CHOLESTEROL, UNIVERSAL ET
K896073 · CHH
Enzyme Technology, Inc.
Chemistry · 54d
Cleared Dec 12, 1989
AMERLITE ESTRADIOL-60 ASSAY LAN.0081/2081
K896270 · CHP
Amersham Corp.
Chemistry · 42d
Cleared Dec 12, 1989
D-CHEM TOTAL T4 TEST KIT FOR THYROXINE QUANTITA.
K896329 · KLI
Photec Diagnostics, Inc.
Chemistry · 40d
Cleared Dec 12, 1989
MODIFIED CEDIA(TM) CORTISOL ASSAY
K896451 · CGR
Microgenics Corp.
Chemistry · 33d
Cleared Dec 07, 1989
CORTISOL TEST SYSTEM
K895421 · JFT
Baxter Healthcare Corp
Chemistry · 97d
Cleared Dec 05, 1989
URIC ACID FOR MANUAL/AUTOMATED APPLICATIONS
K895821 · KNK
Catachem, Inc.
Chemistry · 67d