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
10537–10560 of 13,224
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared May 09, 1983
IMMUNOHEMATOLOGICAL SALINE #97139
K831200 · JCE
Emd Chemicals, Inc.
Chemistry · 28d
Cleared May 09, 1983
IGE-QUANT DIAGNOSTIC TEST KIT
K831208 · DGC
Leeco Diagnostics, Inc.
Chemistry · 25d
Cleared May 09, 1983
CARBAMEZEPINE REAGENT TEST KIT
K831222 · KLT
Beckman Instruments, Inc.
Chemistry · 24d
Cleared May 05, 1983
HELENA BIOSTRIP PH
K830979 · CEN
Helena Laboratories
Chemistry · 37d
Cleared May 05, 1983
DIAGNOSTICS PO2 ELECTRODE CLEANER
K831010 · CHL
Fisher Scientific Co., LLC
Chemistry · 36d
Cleared May 05, 1983
BATH CLEAR
K831016 · CHL
Fisher Scientific Co., LLC
Chemistry · 36d
Cleared May 04, 1983
FLOW-PAC SGOT REAGENT
K830958 · CIT
Amresco, Inc.
Chemistry · 40d
Cleared May 04, 1983
FLOW-PAC SGPT REAGENT
K830959 · CKA
Amresco, Inc.
Chemistry · 40d
Cleared May 04, 1983
IMMUCHEM COVALENT-COAT RIA KIT
K830962 · DPO
Immuchem Corp.
Chemistry · 37d
Cleared May 04, 1983
PLAN A LIFE
K830975 · JIN
New Directions Co.
Chemistry · 40d
Cleared May 04, 1983
HELENA BIOSTRIP K
K830976 · JIN
Helena Laboratories
Chemistry · 36d
Cleared Apr 28, 1983
BLOOD GAS SOLUTIONS & CO-OXIMETER SOLU-
K830843 · JKT
Rna Medical Corp.
Chemistry · 42d
Cleared Apr 28, 1983
VENTREX ENZYME TSH KIT
K830928 · JLW
Ventrex Laboratories, Inc.
Chemistry · 36d
Cleared Apr 28, 1983
HELENA BIOSTRIP P
K830977 · JIR
Helena Laboratories
Chemistry · 30d
Cleared Apr 27, 1983
POTASSIUM ANALYZER-SODIUM/ELECTROLYTE
K830588 · JGS
Shaban Mfg. Co.
Chemistry · 63d
Cleared Apr 27, 1983
ELECTROLYTE STANDARD - CORNING NALK ISE
K830589 · JGS
Shaban Mfg. Co.
Chemistry · 63d
Cleared Apr 27, 1983
ACTH RIA SYSTEM-DSI 2300
K830893 · CKG
Diagnostic Systems Laboratories, Inc.
Chemistry · 37d
Cleared Apr 27, 1983
I.E.C COLUMN
K830918 · KEA
Berwick Medical Products, Inc.
Chemistry · 36d
Cleared Apr 18, 1983
NUCLIPASE (I125) PANCREATIC LIPASE
K823860 · CET
Nuclear Diagnostics, Inc.
Chemistry · 117d
Cleared Apr 18, 1983
WAKO FREE CHOLESTEROL C TEST
K830761 · CHH
Wako Chemicals USA, Inc.
Chemistry · 39d
Cleared Apr 18, 1983
IMMO PHASE DIRECT PROGESTERONE RADIO-
K830880 · JLS
Corning Medical & Scientific
Chemistry · 31d
Cleared Apr 18, 1983
UPTAKE T3 RADIOIMMUNOASSAY KIT
K830900 · KHQ
Medical & Scientific Designs, Inc.
Chemistry · 28d
Cleared Apr 18, 1983
FLOW-PAC TRIGLYCERIDE REAGENT
K830957
Amresco, Inc.
Chemistry · 24d
Cleared Apr 12, 1983
OLYMPUS HIGH SPEED ANALYZER
K830762 · JJE
Olympus Corp.
Chemistry · 33d