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
4921–4944 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Mar 20, 1996
LXN FRUCTOSAMINE TEST
K955629 · JJX
Lxn Corp.
Chemistry · 100d
Cleared Mar 19, 1996
ONE STEP PREGNANCY HCG SERUN DILUENT REAGENT
K955353 · JHI
Tcpi, Inc.
Chemistry · 119d
Cleared Mar 19, 1996
PLATFORM ONESTEP PREGNANCY HOME TEST
K960117 · LCX
Syntron Bioresearch, Inc.
Chemistry · 68d
Cleared Mar 19, 1996
VIVASPIN 4 10,000 MW
K960298 · JJH
Vivascience, Inc.
Chemistry · 57d
Cleared Mar 19, 1996
T-3 MICROWELL EIA MODEL 7013
K960412 · CDP
Biomerica, Inc.
Chemistry · 50d
Cleared Mar 19, 1996
SELFCARE EARLY PREGNANCY TEST
K960436 · LCX
Selfcare, Inc.
Chemistry · 48d
Cleared Mar 13, 1996
ALBUMIN
K955781 · CIX
Derma Media Lab., Inc.
Chemistry · 83d
Cleared Mar 13, 1996
CALCIUM REAGENT
K955939 · CIC
Derma Media Lab., Inc.
Chemistry · 83d
Cleared Mar 13, 1996
TOTAL BILIRUBIN REAGENT
K955940 · CIG
Derma Media Lab., Inc.
Chemistry · 83d
Cleared Mar 12, 1996
SYSCON TURMOR MARKER CONTROL
K955812 · JJY
Scantibodies Laboratory, Inc.
Chemistry · 77d
Cleared Mar 12, 1996
TOTAL PROTEIN REAGENT
K955936 · CEK
Derma Media Lab., Inc.
Chemistry · 82d
Cleared Mar 12, 1996
INORGANIC PHOSPHORUS REAGENT
K955937 · CEO
Derma Media Lab., Inc.
Chemistry · 82d
Cleared Mar 12, 1996
CREATININE REAGENT
K955938 · CGX
Derma Media Lab., Inc.
Chemistry · 82d
Cleared Mar 11, 1996
URINE REAGENTS STRIPS-8 PARAMETERS (MODIFICATION)
K954977 · JRE
Teco Diagnostics
Chemistry · 147d
Cleared Mar 11, 1996
ISE CALIBRANT A & B, ISE LIQUID REAGENT FOR PARAMAX CLINAK SYSTEMS
K960085 · JIX
Alko Diagnostic Corp.
Chemistry · 60d
Cleared Mar 11, 1996
STAT PROFILE ULTRA F,G,H,I,J, AND K ANALYZERS
K960120 · JFP
Nova Biomedical Corp.
Chemistry · 60d
Cleared Mar 11, 1996
SYNERMED ENZYMATIC CO2 REAGENT KIT
K960793 · KHS
Synermed, Inc.
Chemistry · 13d
Cleared Mar 07, 1996
AXSYM PROGESTERONE
K955025 · JLS
Abbott Laboratories
Chemistry · 126d
Cleared Mar 06, 1996
ACCU-CHEK INSTANT PLUS CHOLOESTEROL TEST
K944458 · CHH
Boehringer Mannheim Corp.
Chemistry · 541d
Cleared Mar 06, 1996
SELFCARE EARLY PREGNANCY TEST
K955903 · LCX
Cambridge Diagnostics Ireland, Ltd.
Chemistry · 68d
Cleared Mar 06, 1996
ACTIVE T3 RIA
K960550 · CDP
Diagnostic Systems Laboratories, Inc.
Chemistry · 27d
Cleared Mar 06, 1996
DSL ACTIVE HUMAN GROWTH HORMONE ELISA
K960551 · CFL
Diagnostic Systems Laboratories, Inc.
Chemistry · 27d
Cleared Feb 29, 1996
ACCUSTAT HCG SERUM DILUENT REAGENT OR EVENT SERUM DILUENT
K955266 · JHI
Boehringer Mannheim Italia Spa
Chemistry · 106d
Cleared Feb 29, 1996
SERUM BICARBONATE/CARBON DIOXIDE
K955302 · KHS
Data Medical Associates, Inc.
Chemistry · 101d