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
4801–4824 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Jul 22, 1996
DOCUMENT AMMONIA, ETHANOL, LACTATE ASSAYED CONTROL
K962630 · JJY
Casco Standards
Chemistry · 17d
Cleared Jul 22, 1996
OPUS B12 CONTROLS
K962694 · JJX
Behring Diagnostics, Inc.
Chemistry · 11d
Cleared Jul 19, 1996
SENTINEL LIPASE LIQUID MODEL 17.401B
K961179 · CHI
Equal Diagnostics, Inc.
Chemistry · 115d
Cleared Jul 17, 1996
HYDRASYS AGAROSE GEL ELECTROPHORESIS APPARATUS/HYDRAGEL 15,30 PROTEIN KIT
K960029 · CEF
Morax
Chemistry · 197d
Cleared Jul 16, 1996
NICHOLS ADVANTAGE CHEMILUMINESCENCE THYROID STIMULATING HORMONE THIRD...
K961650 · JLW
Nichols Institute Diagnostics
Chemistry · 77d
Cleared Jul 16, 1996
N CRP STANDARD SY
K962406 · JIX
Behring Diagnostics, Inc.
Chemistry · 25d
Cleared Jul 12, 1996
FREE TRIIODOTHYRONINE(FT3) ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN-VITRO...
K962355 · CDP
Bayer Corp.
Chemistry · 24d
Cleared Jul 11, 1996
OSTEOMARK
K961562 · JMM
Ostex Intl., Inc.
Chemistry · 80d
Cleared Jul 11, 1996
ADVANCED MICRO-OSMOMETER MODEL 3300
K962056 · JJM
Advanced Instruments, Inc.
Chemistry · 44d
Cleared Jul 10, 1996
BIODATA SR1 FAH-HCG ENZYME IMMUNOASSAY KIT
K954065 · JHI
Biochem Immunosystems (U.S.), Inc.
Chemistry · 315d
Cleared Jul 10, 1996
BRAND NAME 1-STEP PREGNANCY TEST-MAY BE MARKETED UNDER FIRST RESPONSE,...
K962183 · LCX
Armkel, LLC
Chemistry · 34d
Cleared Jul 08, 1996
CDM
K960392 · LDM
Bio-Rad
Chemistry · 161d
Cleared Jul 08, 1996
HUMAN GROWTH HORMONE IMMUNOASSAY KIT
K961678 · CFL
Nichols Institute Diagnostics
Chemistry · 68d
Cleared Jul 08, 1996
UBI MAGIWEL THYROXINE (T4) QUANTITATIVE
K962211 · KLI
United Biotech, Inc.
Chemistry · 28d
Cleared Jul 05, 1996
CHEK-STIX U.T.I. SELF-TEST
K960888 · JMT
Bayer Corp.
Chemistry · 123d
Cleared Jul 05, 1996
OLYMPUS AU600 CLINICAL CHEMISTRY ANALYZER
K961274 · JJE
Olympus America, Inc.
Chemistry · 94d
Cleared Jul 05, 1996
LIQUISPEX URINE (MICRO)ALBUMIN CONTROL
K962432 · JJX
Clinical Controls, Inc.
Chemistry · 11d
Cleared Jul 01, 1996
FIRST CHOICE URINARY TRACT INFECTION TEST STRIPS
K953672 · JMT
Polymer Technology Intl.
Chemistry · 329d
Cleared Jul 01, 1996
DMA GAMMA GLUTAMYLTRANSFERASE (GGT) PROCEDURE
K961919 · JPZ
Data Medical Associates, Inc.
Chemistry · 45d
Cleared Jun 28, 1996
AMYLASE (KINETIC) REAGENT SET
K915704 · CJD
Tech Intl. Co.
Chemistry · 1675d
Cleared Jun 28, 1996
IN VITRO DIAGNOSTIC REAGENT SET, INDIR. PREG. TEST
K921968 · JHJ
Tech-Co, Inc.
Chemistry · 1523d
Cleared Jun 28, 1996
LXN BLOOD GLUCOSE TEST SYSTEM
K960034 · CGA
Lxn Corp.
Chemistry · 177d
Cleared Jun 28, 1996
SELFCARE BLOOD GLUCOSE TEST STRIPS FOR THE EXACTECH SYSTEM
K960053 · CGA
Selfcare, Inc.
Chemistry · 176d
Cleared Jun 28, 1996
GEM PREMIER PLUS MODEL 5500
K961335 · CHL
Mallinckrodt Sensor Systems, Inc.
Chemistry · 81d