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
6073–6096 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Oct 09, 1992
VISTA THYROXINE UPTAKE ASSAY
K923676 · KHQ
Syva Co.
Chemistry · 79d
Cleared Oct 05, 1992
ICN BIOMEDICALS IMMUCHEM(TM) FSH-MW ELISA KIT
K922376 · CGJ
Icn Biomedicals, Inc.
Chemistry · 138d
Cleared Oct 05, 1992
IMMUCHEM PRL-MW ELISA
K922715 · CFT
Icn Biomedicals, Inc.
Chemistry · 122d
Cleared Oct 05, 1992
KING DIAGNOSTICS CHLORIDE REAGENT
K922921 · CHJ
King Diagnostics, Inc.
Chemistry · 110d
Cleared Oct 02, 1992
OLYMPUS AMYLASE REAGENT
K923346 · JFJ
Olympus Corp.
Chemistry · 94d
Cleared Oct 02, 1992
OLYMPUS TOTAL BILIRUBIN REAGENT
K923609 · CIG
Olympus Corp.
Chemistry · 79d
Cleared Oct 02, 1992
OLYMPUS CHLORIDE REAGENT
K923610 · CHJ
Olympus Corp.
Chemistry · 81d
Cleared Oct 01, 1992
VISUAL HCG PREGNANCY TEST
K923376 · JHI
Tech-Co, Inc.
Chemistry · 84d
Cleared Sep 30, 1992
IL TEST GLUCOSE, PN 181633-80
K922532 · CGA
Instrumentation Laboratory CO
Chemistry · 125d
Cleared Sep 30, 1992
KING DIAGNOSTICS MAGNESIUM REAGENT
K923927 · JGJ
King Diagnostics, Inc.
Chemistry · 56d
Cleared Sep 29, 1992
ANALYZER: NOVA 10 CRT ANALYZER & QUALI CONT MATER
K923806 · JGS
Nova Biomedical Corp.
Chemistry · 62d
Cleared Sep 29, 1992
ATAC 6000 CHEMISTRY ANALYZER
K924084 · JJE
Bio-Chem Laboratory Systems, Inc.
Chemistry · 47d
Cleared Sep 28, 1992
GAMMA GULTAMYL TRANSFERASE TEST
K922947 · JQB
Em Diagnostic Systems, Inc.
Chemistry · 102d
Cleared Sep 28, 1992
MILES URINE AMYLASE METHOD
K923105 · JFJ
Heraeus Kulzer, Inc.
Chemistry · 101d
Cleared Sep 28, 1992
EMDS ALANINE AMINOTRANSFER TEST(ALT) TECH RA 1000
K923257 · CKA
Em Diagnostic Systems, Inc.
Chemistry · 88d
Cleared Sep 28, 1992
OLYMPUS ALKALINE PHOSPHATASE REAGENT
K923527 · CJE
Olympus Corp.
Chemistry · 74d
Cleared Sep 28, 1992
OLYMPUS IRON REAGENT
K923565 · JIY
Olympus Corp.
Chemistry · 73d
Cleared Sep 25, 1992
KODAK AMERLITE TOTAL THYROID CONTROL SERA
K923740 · JJY
Eastman Kodak Company
Chemistry · 60d
Cleared Sep 23, 1992
TITAN GEL ALKALINE PHOSPHATASE (HR)
K921578 · CIN
Helena Laboratories
Chemistry · 174d
Cleared Sep 23, 1992
GLUCOSE 3
K922035 · CGA
Caro Med, Inc.
Chemistry · 145d
Cleared Sep 23, 1992
DU PONT ACA MASS CREATIVE KINASE MB (MCKMB) CALIBR
K922699 · JIS
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 111d
Cleared Sep 23, 1992
ENCORE TEST STRIPS
K923018 · CFR
Heraeus Kulzer, Inc.
Chemistry · 92d
Cleared Sep 23, 1992
TECHNICON IMMUNO 1 SYSTEM TOTAL TRIIODOTHYRONINE
K923258 · CDP
Heraeus Kulzer, Inc.
Chemistry · 83d
Cleared Sep 22, 1992
MILES SODIUM METHOD
K923037 · JOS
Heraeus Kulzer, Inc.
Chemistry · 95d