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
5401–5424 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Nov 10, 1994
DUPONT ACA STAR
K941050 · JJQ
Dupont Medical Products
Chemistry · 248d
Cleared Nov 10, 1994
BIO-RAD CLINICAL DATA MANAGEMENT SYSTEM
K942451 · LDM
Bio-Rad
Chemistry · 171d
Cleared Nov 10, 1994
DSL ACTIVE 17A-OH PROGESTERONE RIA (DSL 5000)
K943148 · JLX
Diagnostic Systems Laboratories, Inc.
Chemistry · 133d
Cleared Nov 10, 1994
VALPROIC ACID FPIA REAGENT SET AND CALIBRATORS
K943866 · LEG
Sigma Diagnostics, Inc.
Chemistry · 94d
Cleared Nov 10, 1994
FLUORESCENCE POLARIZATION IMMUNOASSAY CARBAMAZEPINE
K944063 · LGI
Sigma Diagnostics, Inc.
Chemistry · 83d
Cleared Nov 10, 1994
DIMENSION(R) XL CLINICAL CHEMISTRY SYSTEM
K944093 · JJE
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 80d
Cleared Nov 10, 1994
TOBRAMYCIN FPIA REAGENT SET AND CALIBRATOR
K944371 · LFW
Sigma Diagnostics, Inc.
Chemistry · 64d
Cleared Nov 10, 1994
VACUTAINER BRAND PLUS SODIUM HEPARIN TUBE
K944566 · JKA
Bd Becton Dickinson Vacutainer...
Chemistry · 50d
Cleared Nov 08, 1994
CHEMSTRIP MINI UA URINE ANALYZER
K943592 · KQO
Boehringer Mannheim Corp.
Chemistry · 106d
Cleared Nov 04, 1994
SIGMA GLUCOSE REAGENT
K933694 · CGA
Sigma Chemical Co.
Chemistry · 463d
Cleared Nov 04, 1994
CKMB/MYOGLOBIN MASS MEASUREMENY CONTROL LEVEL 1, 2, 3,
K944923 · JJT
Clinical Controls, Inc.
Chemistry · 29d
Cleared Nov 02, 1994
SYNCHRON CX3 DELTA
K942676 · JJF
Beckman-Diagnostic Systems Group
Chemistry · 149d
Cleared Nov 02, 1994
ENZYME-LINKED FLUORESCENT IMMUNOASSAY
K943811 · CFT
Biomerieux Vitek, Inc.
Chemistry · 89d
Cleared Nov 02, 1994
FLUIDS PACK
K944516 · JIT
Alko Diagnostic Corp.
Chemistry · 48d
Cleared Nov 02, 1994
MULTI LEVEL THC ASSAY, SYNCHRON CX REAGENT APPLICATION
K944562 · LDJ
Microgenics Corp.
Chemistry · 64d
Cleared Oct 31, 1994
HCG/TSH CONTROL- LEVEL 1/LEVEL 2/LEVEL 3
K935599 · JJY
Clinical Controls, Inc.
Chemistry · 346d
Cleared Oct 31, 1994
ROCHE REAGENT
K941573 · CHH
Roche Diagnostic Systems, Inc.
Chemistry · 214d
Cleared Oct 31, 1994
IMMULITE SHBG
K941797 · CDZ
Diagnostic Products Corp.
Chemistry · 202d
Cleared Oct 31, 1994
FOLIC ACID
K943705 · CGN
Diagnostic Products Corp.
Chemistry · 91d
Cleared Oct 31, 1994
NEGATIVE CONTROL STRIPS FOR URINALYSIS (CHEX-STIX, CLINITEK AUTO 2000,...
K943780 · JJW
Heraeus Kulzer, Inc.
Chemistry · 89d
Cleared Oct 31, 1994
CARDIOCHEX CKMB MASS MEASUREMENT CONTROL
K944246 · JJT
Cala Diagnostics
Chemistry · 61d
Cleared Oct 31, 1994
CARDIOCHEX CKMB IMMUNOINHIBITION CONTROL
K944247 · JJT
Cala Diagnostics
Chemistry · 61d
Cleared Oct 27, 1994
MONOJECT SAMPLETTE SEPARATOR TUBE
K941291 · GIO
Sherwood Medical Co.
Chemistry · 224d
Cleared Oct 27, 1994
SOLARCARE TOTAL PROTEIN MICRO-PLATE ASSAY
K941496 · CEK
Solarcare, Inc.
Chemistry · 213d