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
10777–10800 of 13,224
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Nov 16, 1982
QAP MICROCOMPUTER SYSTEM
K823110 · JQP
American Dade
Chemistry · 26d
Cleared Nov 10, 1982
ID-ZONE LD ISOENZYME CONTROL
K822984 · JJT
Beckman Instruments, Inc.
Chemistry · 29d
Cleared Nov 10, 1982
NML-TETRA-TUBE RIA
K823053 · CDX
Nuclear Medical Laboratories, Inc.
Chemistry · 23d
Cleared Nov 10, 1982
KENAMYCIN FLUORESCENT IMMUNOASSAY FIA
K823062 · KJI
American Diagnostic Corp.
Chemistry · 23d
Cleared Nov 10, 1982
GENERIC PREGNANCY TEST
K823109 · LCX
Diagnostic Specialties
Chemistry · 20d
Cleared Nov 05, 1982
HOME BLOOD GLUCOSE MONITOR
K822486 · CGA
Pharmaquest Corp.
Chemistry · 80d
Cleared Nov 05, 1982
DIGITAL DILUTER/DISPENSERS
K822688 · JQW
Hamilton Co.
Chemistry · 63d
Cleared Nov 05, 1982
GLUCOSCAN METER MODEL II
K822699 · CGA
Lifescan, Inc.
Chemistry · 59d
Cleared Nov 05, 1982
SOLID PHASE SIMUL TRAC VITAMIN B12
K822728 · CGN
Bd Becton Dickinson Vacutainer...
Chemistry · 58d
Cleared Nov 05, 1982
COAT-A-COUNT FREE THYROXINE KIT/COMPONEN
K822882 · CEC
Diagnostic Products Corp.
Chemistry · 45d
Cleared Nov 05, 1982
EMIT CLINICAL PROCESSOR #CP-5000
K822932 · JQP
Syva Co.
Chemistry · 32d
Cleared Nov 05, 1982
GLUCOSE/UREA NITROGEN STANDARD
K822937 · JIX
Emd Chemicals, Inc.
Chemistry · 32d
Cleared Nov 05, 1982
PHADEBASE HUMYLASE CONTROL
K822938 · JJX
Pharmacia, Inc.
Chemistry · 32d
Cleared Nov 05, 1982
LANCER MSH GLUCOSE DIAG. KIT
K822958 · CGA
Sherwood Medical Co.
Chemistry · 31d
Cleared Nov 05, 1982
BIO MAG TOTAL T4 RADIOIMMUNOASSAY KIT
K823004 · CDX
Bioclinical Group
Chemistry · 24d
Cleared Nov 05, 1982
KM-KAL L1
K823042 · JIX
Kmn Products, Inc.
Chemistry · 21d
Cleared Nov 05, 1982
KM-KAL L2
K823043 · JIX
Kmn Products, Inc.
Chemistry · 21d
Cleared Nov 05, 1982
KM-KAL L4
K823045 · JIX
Kmn Products, Inc.
Chemistry · 21d
Cleared Nov 05, 1982
KM-KAL L5
K823046 · JIX
Kmn Products, Inc.
Chemistry · 21d
Cleared Nov 01, 1982
TITAN GEL CPK ISOENZYME SYSTEM
K822124 · JHT
Helena Laboratories
Chemistry · 105d
Cleared Nov 01, 1982
CORTISOL RIA KIT
K822892 · CGR
Antibodies, Inc.
Chemistry · 34d
Cleared Nov 01, 1982
THYROID STIMULATING HORMONE
K822935 · JLW
Pcl-Ria, Inc.
Chemistry · 28d
Cleared Oct 27, 1982
TPK 1980/1
K822449 · LCX
Plantex USA, Inc.
Chemistry · 72d
Cleared Oct 27, 1982
MICROFLUOR READER
K822772 · KHO
Dynatech Corp.
Chemistry · 43d