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.

176,325 clearances · 1976 to present · Updated monthly from FDA records

Filters: Chemistry ×
13,249 results
10057–10080 of 13,249
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Apr 04, 1984
PROGRESS SELECTIVE DHEMISTRY ANALYZ
K840200 · JJF
Kone Instruments, Inc.
Chemistry · 76d
Cleared Apr 04, 1984
PARATHYROID HORMONE ANALYSIS PRODUCT
K840379 · CEW
Nichols Institute Diagnostics
Chemistry · 68d
Cleared Apr 04, 1984
VENTREZYME T4 IMMUNOASSAY T4
K840473 · KLI
Vxr, Inc.
Chemistry · 61d
Cleared Apr 04, 1984
ACCULAB SUPPLIES CHEMICAL ANALYZERS
K840501 · JJE
Precision Technology, Inc.
Chemistry · 58d
Cleared Apr 04, 1984
CATS-CLINICAL LAB COMPUTER SOFTWARE-
K840502 · JQP
Precision Technology, Inc.
Chemistry · 58d
Cleared Apr 04, 1984
REAGENTS & STANDARDS IL 501 NA/K
K840557 · JGS
Shaban Mfg. Co.
Chemistry · 56d
Cleared Apr 04, 1984
AMERLEX HUMAN PLACENTAL LACTOGEN
K840588 · JMF
Amersham Corp.
Chemistry · 55d
Cleared Apr 04, 1984
EKTACHEM CLINICAL CHEM. SLIDES
K840606 · CIG
Eastman Kodak Company
Chemistry · 54d
Cleared Apr 04, 1984
LIQUI-URA CHEMISTRY URINE CONTROLS
K840618 · JJW
Biodiagnostic Intl
Chemistry · 50d
Cleared Apr 04, 1984
B-NEOCEPT 30
K840650 · JHJ
Organon, Inc.
Chemistry · 49d
Cleared Apr 04, 1984
PDC HDL EZ-SEP CHOLESTEROL REAGENT
K840676 · LBS
Preventive Diagnostics Corp.
Chemistry · 49d
Cleared Apr 04, 1984
PARAMAX AMMONIA REAGENTT
K840770 · JIF
American Dade
Chemistry · 67d
Cleared Apr 04, 1984
CARBON DIOXIDE REAGENT
K840773 · KHS
American Dade
Chemistry · 56d
Cleared Apr 04, 1984
CARBON DIOXIDE CALIBRATOR I
K840774 · JIT
American Dade
Chemistry · 56d
Cleared Apr 04, 1984
CARBON DIOXIDE CALIBRATOR II
K840775 · JIT
American Dade
Chemistry · 56d
Cleared Apr 04, 1984
PARAMAX CHOLESTEROL REAGENT
K840776 · CHH
American Dade
Chemistry · 56d
Cleared Apr 04, 1984
CREATINE KINASE MB REAGENT
K840783 · CGS
American Dade
Chemistry · 49d
Cleared Apr 01, 1984
IMMPULSE TBC ASSAY REAGENTS
K840853 · KHQ
Paragon Diagnostics, Inc.
Chemistry · 37d
Cleared Mar 30, 1984
WESCOR 5500 VAPOR PRESSURE OSMOMETER
K834214 · JJM
Wescor, Inc.
Chemistry · 116d
Cleared Mar 30, 1984
THYROXINE EMIA
K840241 · KLI
Collaborative Research, Inc.
Chemistry · 70d
Cleared Mar 30, 1984
MCS TOTAL PROTEIN REAGENT
K840290 · CEK
Medilab Corp.
Chemistry · 66d
Cleared Mar 30, 1984
MCS ALBUMIN REAGENT
K840291 · CIX
Medilab Corp.
Chemistry · 66d
Cleared Mar 30, 1984
RIANEN ESTRIOL RADIOIMMUNOASSAY KIT
K840301 · CGI
New England Nuclear
Chemistry · 66d
Cleared Mar 30, 1984
DURAZYME CHOLESTEROL
K840368 · CHH
American Monitor Corp.
Chemistry · 63d