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
10801–10824 of 13,224
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Oct 27, 1982
PICOLITE
K822800 · JJQ
United Technologies Packard
Chemistry · 40d
Cleared Oct 27, 1982
HISH EIA DIAGNOSTIC KIT
K822827 · JLW
Abbott Laboratories
Chemistry · 36d
Cleared Oct 27, 1982
RADIOIMMUNOASSAY, HUMAN CHORRIONIC
K822840 · JHI
Bioclinical Group
Chemistry · 34d
Cleared Oct 27, 1982
SOPHEIA CORTISOL EIA KIT
K822845 · CGR
Diagnostic Products Corp.
Chemistry · 34d
Cleared Oct 27, 1982
MONI-TRO ES CHEMISTRY CONTROL LEVEL IX
K822850 · JJY
American Dade
Chemistry · 34d
Cleared Oct 27, 1982
TRIGLYCERIDE CALIBRATOR
K822852 · JIT
Harleco Diagnostics
Chemistry · 33d
Cleared Oct 27, 1982
RIA SSIST TI-59 MAGNETIC CARD PROGRAMS
K822860 · JQP
Ventrex Laboratories, Inc.
Chemistry · 30d
Cleared Oct 27, 1982
URIC ACID 75CDO
K822884 · CDO
Technicon Instruments Corp.
Chemistry · 29d
Cleared Oct 27, 1982
SYVA ADVANCE EMIT AED VALPROIC ACID ASSA
K822933 · LEG
Syva Co.
Chemistry · 23d
Cleared Oct 26, 1982
FOLATE/B12 DUO-BEAD RADIOASSAY
K822241 · CEN
Abbott Laboratories
Chemistry · 91d
Cleared Oct 26, 1982
MICROMEDIC ESTRIOL RIA KIT
K822578 · CGI
Micromedic Systems
Chemistry · 62d
Cleared Oct 26, 1982
NETILMICIN FLUORESCENT IMMUNOASSAY
K822941 · LCE
American Diagnostic Corp.
Chemistry · 22d
Cleared Oct 21, 1982
BECKMAN ASTRA
K822039 · JGS
Beckman Instruments, Inc.
Chemistry · 101d
Cleared Oct 21, 1982
NEW ENZYMATIC SINGLE REAGENT FREE CHOL.
K822417 · CHH
Sclavo, Inc.
Chemistry · 71d
Cleared Oct 21, 1982
ABBOTT LABORATORIES PROLACTIN EIA
K822759 · CFT
Abbott Laboratories
Chemistry · 37d
Cleared Oct 18, 1982
SERAGAN ACTH125 I-RIA KIT
K822115 · CKG
Seragen Diagnostics, Inc.
Chemistry · 91d
Cleared Oct 18, 1982
AHBD
K822739 · JMK
Gilford Diagnostics
Chemistry · 39d
Cleared Oct 18, 1982
COAT-A-COUNT TOBRAMYCIN RIA KIT
K822858 · KLB
Diagnostic Products Corp.
Chemistry · 21d
Cleared Oct 13, 1982
TAMDEM-R THYROID STIMULATING HORMONE KIT
K822705 · JLW
Hybritech, Inc.
Chemistry · 36d
Cleared Oct 08, 1982
UNIMETER 330K
K822441 · CEM
Boehringer Mannheim Corp.
Chemistry · 53d
Cleared Oct 08, 1982
COUNT-10 TROL
K822540 · JJW
Texas Immunology, Inc.
Chemistry · 46d
Cleared Oct 08, 1982
ADVANCE TM T-3 UPTAKE ASSAY
K822592 · KHQ
Syva Co.
Chemistry · 31d
Cleared Oct 08, 1982
FLUOROSTAT FLUOROMETER
K822701 · KHO
Miles Laboratories, Inc.
Chemistry · 31d
Cleared Oct 08, 1982
MODEL 340 SPECTROPHOTOMETER
K822720 · JJQ
Abbott Diagnostics
Chemistry · 31d