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
10921–10944 of 13,224
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Jul 14, 1982
ULTRAZYME PLUS HBD
K821877 · JMK
Harleco Diagnostics
Chemistry · 19d
Cleared Jul 14, 1982
ULTRAZYME PLUS LDH
K821878 · CFJ
Harleco Diagnostics
Chemistry · 19d
Cleared Jul 14, 1982
ULTRACHEM T.P.
K821879 · CEX
Harleco Diagnostics
Chemistry · 19d
Cleared Jul 14, 1982
ULTRA CHEM ALB
K821880 · CIX
Harleco Diagnostics
Chemistry · 19d
Cleared Jul 14, 1982
ULTRACHEM CREA
K821881 · CGX
Harleco Diagnostics
Chemistry · 19d
Cleared Jul 14, 1982
ULTRAZYME PLUS GPT
K821882 · CKA
Harleco Diagnostics
Chemistry · 19d
Cleared Jul 14, 1982
ULTRAZYME PLUS CK-I
K821883 · CGS
Harleco Diagnostics
Chemistry · 19d
Cleared Jul 13, 1982
HUMAN C-PEPTIDE OF INSULIN BY RADIOIMM.
K820666 · JKD
Immuno Nuclear Corp.
Chemistry · 124d
Cleared Jul 13, 1982
ALBUMIN REAGENT SET
K821193 · CIX
Omega Medical Electronics
Chemistry · 77d
Cleared Jul 13, 1982
CHOLESTEROL REAGENT SET
K821195 · CHD
Omega Medical Electronics
Chemistry · 77d
Cleared Jul 13, 1982
SERUM CALCIUM REAGENT SET
K821196 · CIC
Omega Medical Electronics
Chemistry · 77d
Cleared Jul 13, 1982
TOTAL BILIRUBIN REAGENT SET
K821197 · CIG
Omega Medical Electronics
Chemistry · 77d
Cleared Jul 13, 1982
DIRECT GLUCOSE REAGENT SET
K821198 · CGE
Omega Medical Electronics
Chemistry · 77d
Cleared Jul 13, 1982
CREATININE REAGENT SET
K821199 · CGX
Omega Medical Electronics
Chemistry · 77d
Cleared Jul 13, 1982
ALKALINE PHOSPHOTASE REAGENT SET
K821200 · CIO
Omega Medical Electronics
Chemistry · 77d
Cleared Jul 13, 1982
HDL PRECIPITANT REAGENT SET
K821203 · LBR
Omega Medical Electronics
Chemistry · 77d
Cleared Jul 13, 1982
SERUM TOTAL PROTEIN REAGENT SET
K821210 · CEK
Omega Medical Electronics
Chemistry · 77d
Cleared Jul 13, 1982
URIC ACID REAGENT SET
K821213 · CDH
Omega Medical Electronics
Chemistry · 77d
Cleared Jul 13, 1982
GEMSTAR SYSTEM
K821335 · JJE
Electro-Nucleonics Laboratories, Inc.
Chemistry · 69d
Cleared Jul 13, 1982
LEVEL I LIPID CONTROL
K821559 · JJY
Irvine Scientific
Chemistry · 49d
Cleared Jul 13, 1982
LEVEL II LIPID CONTROL
K821560 · JJY
Irvine Scientific
Chemistry · 49d
Cleared Jul 13, 1982
ULTRAZYME PLUS AMYL
K821869 · JFJ
Harleco Diagnostics
Chemistry · 18d
Cleared Jul 13, 1982
ULTRAZYME PLUS ALP
K821870 · CJE
Harleco Diagnostics
Chemistry · 18d
Cleared Jul 13, 1982
ULTRACHEM PHOS
K821874 · CEO
Harleco Diagnostics
Chemistry · 18d