FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,218 clearances · 1976 to present · Updated monthly from FDA records

Filters: Chemistry ×
13,224 results
11041–11064 of 13,224
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared May 14, 1982
TSH-SQUIBB RADIOIMMUNOASSAY KIT
K821174 · JLW
Squibb & Sons, Inc.
Chemistry · 18d
Cleared May 14, 1982
GASTRIN RADIOIMMUNOASSAY KIT (125-I)
K821175 · CGC
Bd Becton Dickinson Vacutainer...
Chemistry · 18d
Cleared May 14, 1982
VISIDEX REAGENT STRIPS
K821179 · CGA
Miles Laboratories, Inc.
Chemistry · 17d
Cleared May 14, 1982
TARGET ISOCHECK CONTROL SERUM
K821183 · JJT
Smithkline Diagnostics, Inc.
Chemistry · 17d
Cleared May 13, 1982
KALLESTAD QUANTIZYME THEOPHYLLINE ENZYME
K821154 · KLS
Jay Rau, Technical Suppprt
Chemistry · 17d
Cleared May 12, 1982
SIMUL-FER SERUM IRON TEST KIT
K820253 · JJA
Diagnostic Reagents, Inc.
Chemistry · 103d
Cleared May 12, 1982
FETAL-TEK CONTROL (IMMATURE/BORDERLINE)
K820772 · JJX
Helena Laboratories
Chemistry · 50d
Cleared May 12, 1982
HI-PHORE HIGH RESOLUTION ELECTROPHORES
K821303 · JJN
Gelman Sciences, Inc.
Chemistry · 8d
Cleared May 10, 1982
TECHNICON RA-1000 SYS, ANALYTES III
K821514 · JEJ
Technicon Instruments Corp.
Chemistry
Cleared May 05, 1982
AUTOMATED URINALYSIS SYSTEM
K813056 · KQO
Kyoto Daiichi Kagaku Co., Ltd.
Chemistry · 188d
Cleared May 05, 1982
T4 DIAGNOSTIC KIT
K820251 · CDP
Diagnostic Reagents, Inc.
Chemistry · 96d
Cleared May 05, 1982
TBG DIAGNOSTIC KIT
K820252 · CEE
Diagnostic Reagents, Inc.
Chemistry · 96d
Cleared May 05, 1982
BIOSTRIP G
K820594 · JIL
Helena Laboratories
Chemistry · 62d
Cleared May 05, 1982
DSL 1020
K821068 · CGR
Diagnostic Systems Laboratories, Inc.
Chemistry · 19d
Cleared May 05, 1982
TOTAL RADIOIMMUNOASSAY KIT
K821101 · CDX
Bioclinical Group
Chemistry · 15d
Cleared May 05, 1982
MEGNESIUM REAGENT KIT
K821102 · JGJ
Anco Medical Reagents & Assoc.
Chemistry · 15d
Cleared May 05, 1982
CHOLESTEZYME-V EIKEN
K821105 · CHH
Syn-Kit, Inc.
Chemistry · 15d
Cleared May 05, 1982
TRIGLYZYME V EIKEN
K821106 · JGY
Syn-Kit, Inc.
Chemistry · 15d
Cleared May 03, 1982
RA-1000 SYSTEM ADD'L ANALYTES PHASE III
K820913 · CEK
Technicon Instruments Corp.
Chemistry · 32d
Cleared May 03, 1982
ROCHE(R) B-HCG RIA URINE STANDARD
K820942 · JHI
Hoffmann-La Roche, Inc.
Chemistry · 27d
Cleared May 03, 1982
ECLIPSE
K821007 · JQW
Scientific Software & Instrument Co.
Chemistry · 24d
Cleared May 03, 1982
ACE ACTIVITY MICROVIAL TEST SET
K821011 · KQN
Ventrex Laboratories, Inc.
Chemistry · 21d
Cleared May 03, 1982
NOVA II FLUIDS PACK
K821030 · JIX
Shaban Mfg. Co.
Chemistry · 20d
Cleared May 03, 1982
AMERLEX B-LCG RIA KIT
K821031 · JHI
Amersham Corp.
Chemistry · 20d