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
9913–9936 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Jun 07, 1984
DEMAND C02
K841726 · KHS
Cooper Biomedical, Inc.
Chemistry · 43d
Cleared Jun 07, 1984
RAICHEM BILIRUBIN REAGENT TOTAL/DIRECT
K841892 · CIG
Reagents Applications, Inc.
Chemistry · 31d
Cleared Jun 07, 1984
CM-TRISACRYL M DEAE-TRISACRYL M
K842028 · KEA
Lkb Instruments, Inc.
Chemistry · 20d
Cleared Jun 05, 1984
OREIA II B-HCG PREGNANCY TEST KIT
K841525 · JHI
Organon, Inc.
Chemistry · 54d
Cleared Jun 05, 1984
DUPONT ACA LIQUID BILIRUBIN CALIBRATOR
K842222
E.I. Dupont DE Nemours & Co., Inc.
Chemistry
Cleared May 31, 1984
HEALTHCHECK HOME PREGNANCY TEST KIT
K841595 · LCX
Timex Medical Products Corp.
Chemistry · 43d
Cleared May 31, 1984
TDX REA URIC ACID
K841702 · KNK
Abbott Laboratories
Chemistry · 38d
Cleared May 31, 1984
KYOTEST UG URINE TEST REAGENT STRIP
K841713 · JIL
Kyoto Diagnostics, Inc.
Chemistry · 37d
Cleared May 31, 1984
KYOTEST 2V, URINE TEST REAGENT STRIP
K841714 · JIL
Kyoto Diagnostics, Inc.
Chemistry · 37d
Cleared May 31, 1984
KYOTEST UK URINE TEST REAGENT STRIP
K841715 · JIN
Kyoto Diagnostics, Inc.
Chemistry · 37d
Cleared May 31, 1984
ELVI 70 SAFETY CHAMBER
K841804 · JJN
Logos Scientific, Inc.
Chemistry · 30d
Cleared May 30, 1984
ELVI 444 BILITRON
K840757 · CIG
Logos Scientific, Inc.
Chemistry · 97d
Cleared May 30, 1984
PREG BETA BLUS SLIDE
K840833 · JHJ
Intl. Diagnostic, Inc.
Chemistry · 96d
Cleared May 30, 1984
TRIGLYCERIDE ASSAY KIT-COLORIMETRIC
K842157
Diagnostic Chemicals, Ltd. (Usa)
Chemistry
Cleared May 25, 1984
COMPONENTS FOR PARTIAL PRESSURE ELEE
K841609 · CHL
Shaban Mfg. Co.
Chemistry · 46d
Cleared May 25, 1984
COMPONENTS FOR POTASSIUM, SODIUM CHLO
K841610 · JGT
Shaban Mfg. Co.
Chemistry · 46d
Cleared May 22, 1984
AMRESCO E4A REAGENT SET
K840868 · JJE
American Research Products Co.
Chemistry · 85d
Cleared May 22, 1984
LINEAR CLOUD TONOMETER
K841089 · LCH
Linear Tonometers, Inc.
Chemistry · 70d
Cleared May 22, 1984
TAGO DIFFU-GEN C-REACTIVE PROTEIN
K841265 · DCN
Tago, Inc.
Chemistry · 57d
Cleared May 22, 1984
KODAK EKTACHEM DT 60 ANALYZER
K841503 · JJE
Eastman Kodak Company
Chemistry · 42d
Cleared May 22, 1984
SIGMA PROCEDURE 16-UV
K841555 · CFR
Sigma Chemical Co.
Chemistry · 36d
Cleared May 22, 1984
ORTHO MICROWELL READER
K841557 · JJQ
Ortho Diagnostic Systems, Inc.
Chemistry · 36d
Cleared May 22, 1984
TECHNICON RA-1000 SYS T4-THYROXINE
K841576 · KLI
Technicon Instruments Corp.
Chemistry · 35d
Cleared May 22, 1984
TERUMO SENSIBEAD THYROXINE EIA KIT
K841601 · KLI
Terumo Medical Corp.
Chemistry · 34d