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
3577–3600 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Aug 07, 2000
ONE TOUCH ULTRA BLOOD GLUCOSE MONITORING SYSTEM
K002134 · CGA
Selfcare, Inc.
Chemistry · 24d
Cleared Aug 07, 2000
STATLYTE NA/K/CL/LI ANALYZER
K001761 · JGS
Nova Biomedical Corp.
Chemistry · 59d
Cleared Aug 04, 2000
HDL CHOLESTEROL PLUS
K000568 · LBT
Roche Diagnostics Corp.
Chemistry · 164d
Cleared Jul 27, 2000
INVERNESS MEDICAL EARLY PREGNANCY TEST
K002049 · LCX
Selfcare, Inc.
Chemistry · 24d
Cleared Jul 26, 2000
GENERIC BLOOD GLUCOSE TEST STRIP
K001092 · CGA
Inbios Intl., Inc.
Chemistry · 113d
Cleared Jul 24, 2000
ELECSYS SERUM B-CROSSLAPS/SERUM IMMUNOASSAY
K993706 · JMM
Roche Diagnostics Corp.
Chemistry · 265d
Cleared Jul 24, 2000
WAKO AUTOKIT LP(A) AND LP(A) CALIBRATOR/COBAS FARA
K001929 · DFC
Wako Chemicals USA, Inc.
Chemistry · 28d
Cleared Jul 24, 2000
RLP-CHOLESTEROL IMMUNOSEPARATION ASSAY
K001032 · CHH
Otsuka Pharmaceutical Co., Ltd.
Chemistry · 116d
Cleared Jul 21, 2000
RESOLUTION CHOLESTEROL MONITOR
K000610 · CHH
Lifestream Technologies, Inc.
Chemistry · 149d
Cleared Jul 20, 2000
VITROS CHEMISTRY PRODUCTS BUN/UREA SLIDES AND VITROS CHEMISTRY PRODUCTS...
K001885 · CDN
Ortho-Clinical Diagnostics, Inc.
Chemistry · 29d
Cleared Jul 13, 2000
ELECSYS INSULIN CALSET
K001906 · JIS
Roche Diagnostics Corp.
Chemistry · 21d
Cleared Jul 05, 2000
DADE TRU-LIQUID MONI-TROL CHEMISTRY CONTROL LEVELS 1, MID, 2, AND S (ASSAYED)
K001758 · JJY
Medical Analysis Systems, Inc.
Chemistry · 26d
Cleared Jul 03, 2000
EZ LDL CHOLESTEROL TEST SYSTEM
K993741 · MRR
Sigma Diagnostics, Inc.
Chemistry · 242d
Cleared Jul 03, 2000
BIOSCANNER TRIGLYCERIDES TEST STRIPS
K000586 · JGY
Polymer Technology Systems, Inc.
Chemistry · 132d
Cleared Jun 29, 2000
SUGAR CHEX ONE
K001443 · JJX
Streck Laboratories, Inc.
Chemistry · 52d
Cleared Jun 28, 2000
ELECSYS INSULIN CALCHECK
K001846 · JJX
Roche Diagnostics Corp.
Chemistry · 9d
Cleared Jun 28, 2000
VITROS CHEMISTRY PRODUCTS AST SLIDE AND CHEMISTRY PRODUCTS CALIBRATOR KIT 3
K001679 · CIT
Ortho-Clinical Diagnostics, Inc.
Chemistry · 27d
Cleared Jun 26, 2000
INFINITY AMYLASE REAGENT (PROCEDURE NO. 580/568)
K001569 · JFJ
Sigma Diagnostics, Inc.
Chemistry · 38d
Cleared Jun 26, 2000
ADVIA IMS
K001344 · DIH
Bayer Corp.
Chemistry · 60d
Cleared Jun 22, 2000
DBEST HCG 2 IU/ML TEST KIT
K001215 · JHI
Ameritek, Inc.
Chemistry · 69d
Cleared Jun 21, 2000
VITROS CHEMISTRY PRODUCTS CREA DT SLIDES
K001769 · CGX
Ortho-Clinical Diagnostics
Chemistry · 9d
Cleared Jun 19, 2000
OPTI-CHECK PLUS MULTI-ANALYTE CONTROL, MODEL HC7009
K001632 · JJY
Avl Scientific Corp.
Chemistry · 24d
Cleared Jun 19, 2000
CALIBRATION SOLUTION 1, MODEL A943-837
K001484 · JIX
Alko Diagnostic Corp.
Chemistry · 39d
Cleared Jun 19, 2000
QUANTASE PHENYLALANINE SCREENING ASSAY 500 TEST KIT
K000754 · JNB
Quantase , Ltd.
Chemistry · 103d