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
6553–6576 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Jun 17, 1991
MODULE: NOVA NUCLEUS TMG MODULE FLUID PACK
K912321 · JGJ
Nova Biomedical Corp.
Chemistry · 24d
Cleared Jun 10, 1991
DADE LIID-TROL TL TRI-LEVEL LIPID CONTROL
K911854 · JJY
Baxter Healthcare Corp
Chemistry · 45d
Cleared Jun 10, 1991
IL PHOENIX(TM), MODEL 905 CHEM/ELECT ANALYZER
K912016 · JGS
Instrumentation Laboratory CO
Chemistry · 38d
Cleared Jun 10, 1991
SYVA EDMS
K912055 · JJF
Syva Co.
Chemistry · 32d
Cleared Jun 06, 1991
MARK 5 ROBOTIC PIPETTOR
K912228 · JQW
Diagnostic Products Corp.
Chemistry · 17d
Cleared Jun 03, 1991
SYNERMED UREA NITROGEN REAGENT KIT
K911248 · CDQ
Synermed, Inc.
Chemistry · 74d
Cleared May 31, 1991
DIRECTIGEN 1-2-3 PREGNANCY CONTROLS
K911664 · JJX
Quidel Corp.
Chemistry · 49d
Cleared May 28, 1991
SR1 ESTRADIOL ENZYME IMMUNOASSAY
K911396 · CHP
Serono-Baker Diagnostics, Inc.
Chemistry · 60d
Cleared May 24, 1991
SRI TSH IMMUNENZYMETRIC ASSAY
K910837 · JLW
Serono-Baker Diagnostics, Inc.
Chemistry · 86d
Cleared May 23, 1991
TURBO ACCELERATOR W/CLIN DIAG SOFTWARE CARTRIDGE
K911438 · JJQ
Bio-Tek Instruments, Inc.
Chemistry · 51d
Cleared May 23, 1991
INNOFLUOR VALPROIC ACID CALIBRATOR SET
K911466 · DLJ
Intl. Bioclinical, Inc.
Chemistry · 50d
Cleared May 22, 1991
ACTH IRMA KIT MITSUBISHI YUKA
K910178 · CKG
Science Regulatory Services Intl.
Chemistry · 127d
Cleared May 22, 1991
OSMOMETER MODEL 2400
K911092 · JJM
Advanced Instruments, Inc.
Chemistry · 72d
Cleared May 22, 1991
HDL CHOLESTEROL REAGENT
K911406 · LBR
Genzyme Corp.
Chemistry · 54d
Cleared May 22, 1991
MILENIA PROGESTERONE
K911512 · JLS
Diagnostic Products Corp.
Chemistry · 48d
Cleared May 22, 1991
CONTROL FOR PH,BLOOD GASES,ELETROLYTES,GLUCOSE
K911755 · JJY
Bionostics, Inc.
Chemistry · 34d
Cleared May 15, 1991
CLEARVIEW HCG SERUM/URINE
K905741 · JHI
Unipath , Ltd.
Chemistry · 142d
Cleared May 15, 1991
TOTAL BILIRUBIN REAGENT SET
K910635 · CIG
Biochemical Trade, Inc.
Chemistry · 92d
Cleared May 15, 1991
CHOLESTECH L.D.X. LIPID ANALYZER, MODIFICATION
K911578 · CHH
Cholestech Corp.
Chemistry · 49d
Cleared May 15, 1991
VISION BG MONITOR
K911596 · CGA
British-American Medical, Inc.
Chemistry · 36d
Cleared May 15, 1991
STRATUS(R) AUTOMATED SAMPLE HANDLER
K911712 · JQW
Baxter Healthcare Corp
Chemistry · 28d
Cleared May 15, 1991
FIRST CHOICE(TM), MODIFICATION
K911792 · CGA
Polymer Technology Corp.
Chemistry · 23d
Cleared May 15, 1991
HI CHEM AQUEOUS MULTIANALYTE LINE STAND, MODIFIED
K911803 · JJY
Hichem Diagnostics
Chemistry · 22d
Cleared May 10, 1991
DOCUMENT REFLECTANCE II LINEARITY TEST SET
K910440 · JJY
Casco Standards
Chemistry · 99d