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
7201–7224 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Nov 08, 1989
HDL SINGLES
K895381 · LBR
Trace America, Inc.
Chemistry · 71d
Cleared Nov 08, 1989
ONE TOUCH II METER
K895911 · CGA
Lifescan, Inc.
Chemistry · 29d
Cleared Nov 08, 1989
WAKO(TM) AUTOKIT GAMMA-GT
K895984 · JPZ
Wako Chemicals USA, Inc.
Chemistry · 26d
Cleared Oct 31, 1989
OSMOMETER STANDARD SOLUTIONS
K892329 · JIT
D.R.G. Scientific Industries
Chemistry · 209d
Cleared Oct 31, 1989
CEDIA CORTISOL ASSAY
K893954 · JFT
Microgenics Corp.
Chemistry · 152d
Cleared Oct 31, 1989
DOUBLE ANTIBODY GLUCAGON
K893975 · JME
Diagnostic Products Corp.
Chemistry · 151d
Cleared Oct 31, 1989
EOS CHEMISTRY ANALYZER
K894035 · JGS
Eos Technology Corp.
Chemistry · 147d
Cleared Oct 31, 1989
ABBOTT TDX TOTAL T3 PLUS
K894238 · CDP
Abbott Laboratories
Chemistry · 132d
Cleared Oct 31, 1989
LP 400 MICROPLATE READER
K894859 · JJQ
Kallestad Diag, A Div. of Erbamont, Inc.
Chemistry · 92d
Cleared Oct 31, 1989
MILENIA(TM) FSH (MKFS1,5)
K895005 · CGJ
Diagnostic Products Corp.
Chemistry · 84d
Cleared Oct 31, 1989
ACCI-GUARD REUSABLE HOLDER
K895075 · FMI
Medical Safety Products, Inc.
Chemistry · 78d
Cleared Oct 31, 1989
TANDEM-E LH IMMUNOENZYMETRIC ASSAY KIT
K895094 · CEP
Hybritech, Inc.
Chemistry · 78d
Cleared Oct 31, 1989
SYSTEMATE(TM) IRON ITEM NUMBER: 65417
K895249 · JIY
Em Diagnostic Systems, Inc.
Chemistry · 71d
Cleared Oct 31, 1989
SYSTEMATE(TM) ALKALINE PHOSPHATASE ITEM #65402
K895250 · CJE
Em Diagnostic Systems, Inc.
Chemistry · 71d
Cleared Oct 31, 1989
HVA EIA KIT YAMASA
K895288 · CDF
Yamasa Shoy Co., Ltd.
Chemistry · 67d
Cleared Oct 31, 1989
IRMA-COUNT(TM) PAP, (RKPA1, RKPA2)
K895723 · JFH
Diagnostic Products Corp.
Chemistry · 36d
Cleared Oct 30, 1989
CIBA CORNING CERTAIN LYTE
K894576 · JJR
Ciba Corning Diagnostics Corp.
Chemistry · 101d
Cleared Oct 30, 1989
DART UREA NITROGEN
K894836 · CDQ
Coulter Electronics, Inc.
Chemistry · 91d
Cleared Oct 30, 1989
VMA EIA KIT YAMASA
K895287 · CDF
Yamasa Shoy Co., Ltd.
Chemistry · 66d
Cleared Oct 30, 1989
CREATININE 340 (ENZYMATIC)
K895847 · CGX
Sclavo, Inc.
Chemistry · 27d
Cleared Oct 27, 1989
PHENYLALANINE (NINHYDRIN REACTION)
K891070 · JNB
Alpkem Corp.
Chemistry · 240d
Cleared Oct 27, 1989
BUN (KINETIC)
K895666 · CDQ
Boehringer Mannheim Corp.
Chemistry · 37d
Cleared Oct 25, 1989
QUIDEL HCG TEST
K894790 · JHI
Quidel Corp.
Chemistry · 89d
Cleared Oct 25, 1989
COAT-A-COUNT (TM) HCG IRMA
K894941 · JHI
Diagnostic Products Corp.
Chemistry · 83d