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
12601–12624 of 13,249
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Jun 22, 1978
PRINCETON BIOMEDIX HEXOKINASE, GLUCOSE
K780858 · CFR
Bd Becton Dickinson Vacutainer...
Chemistry · 29d
Cleared Jun 22, 1978
RIA SYSTEM FOR HUMAN F-S HORMONE
K780870 · CGJ
Calbiochem-Behring Corp.
Chemistry · 23d
Cleared Jun 22, 1978
EMIT CLINICAL PROCESSOR - CP 5000
K780881 · JQP
Syva Co.
Chemistry · 23d
Cleared Jun 14, 1978
T4-RIA KIT
K780707 · CDX
Clinical Bioresearch
Chemistry · 50d
Cleared Jun 14, 1978
TECHNICON BGII ANALYZER
K780716 · CHL
Technicon Instruments Corp.
Chemistry · 48d
Cleared Jun 14, 1978
DILUTOR TRANSPORTER
K780785 · JQW
Hyland Therapeutic Div., Travenol...
Chemistry · 33d
Cleared Jun 13, 1978
HDL CHOLESTEROL
K780659 · CHH
Macomb Chemical Co.
Chemistry · 54d
Cleared Jun 13, 1978
TSH RIA KIT
K780726 · JLW
Amersham Corp.
Chemistry · 41d
Cleared Jun 13, 1978
PERALISTIC PUMP MODEL 2000
K780789 · JQW
Innovative Medical Systems, Inc.
Chemistry · 29d
Cleared Jun 13, 1978
SGPT/ALT REAGENT SYSTEM
K780791 · CKA
American Monitor Corp.
Chemistry · 29d
Cleared Jun 13, 1978
VITAMIN B12 RADIOASSAY
K780799 · CDD
Amersham Corp.
Chemistry · 29d
Cleared Jun 13, 1978
ISOZYME - ID CPK MARKER
K780801 · JJT
Dade, Baxter Travenol Diagnostics, Inc.
Chemistry · 33d
Cleared Jun 13, 1978
ARMTROL AND FERMTROL
K780802 · JJW
Biotron , Ltd.
Chemistry · 33d
Cleared Jun 13, 1978
URIC ACID RAPID STAT KIT
K780827 · KNK
Pierce Chemical Co.
Chemistry · 25d
Cleared Jun 13, 1978
NINHYDRIN REAGENT KIT
K780847 · JMX
Beckman Instruments, Inc.
Chemistry · 21d
Cleared Jun 06, 1978
CLIN. CHEM. CONTROL SERUM-QUANTITATE
K780554 · JJT
Beckman Instruments, Inc.
Chemistry · 62d
Cleared Jun 06, 1978
125 I-T3 UPTAKE REAGENT
K780671 · CEE
Radioimmunoassay, Inc.
Chemistry · 43d
Cleared Jun 06, 1978
125 I-T4 RIA REAGENT
K780672 · CDX
Radioimmunoassay, Inc.
Chemistry · 43d
Cleared Jun 06, 1978
CENTRIA CORTISOL RIA
K780725 · CGR
Union Carbide Corp.
Chemistry · 34d
Cleared Jun 06, 1978
KRYORACK/4
K780757 · JRR
Streck Laboratories, Inc.
Chemistry · 29d
Cleared Jun 06, 1978
AUTOZYME CHOLESTEROL-OXIDASE REAGENT KIT
K780783 · CHH
J.T. Baker Chemical Co.
Chemistry · 25d
Cleared Jun 06, 1978
TRIIODOTHYRONINE RADIOIMMUNOASSAY KIT
K780787 · CDP
Bd Becton Dickinson Vacutainer...
Chemistry · 25d
Cleared May 26, 1978
DYNEX BLOOD GAS QUALITY CONTROL SYS.
K780144 · JJS
Analytical Products, Inc.
Chemistry · 122d
Cleared May 26, 1978
TOTAL IRON BINDING CAPACITY
K780412 · JQG
Diagnostic Corp. of America
Chemistry · 72d