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
10993–11016 of 13,224
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Jun 10, 1982
TITANAN GEL SERUM PROTEIN ELECTROPHORES
K821517 · JJN
Helena Laboratories
Chemistry · 20d
Cleared Jun 10, 1982
ACID PHOSPHATASE REAGENT SET
K821526 · CKE
Anco Medical Reagents & Assoc.
Chemistry · 20d
Cleared Jun 10, 1982
VAST VENTREX PD IGE RIA TEST SET
K821615 · DGC
Ventrex Laboratories, Inc.
Chemistry · 8d
Cleared Jun 09, 1982
CORDIA TG
K821489 · JZO
Cordis Corp.
Chemistry · 22d
Cleared Jun 03, 1982
ULTRACHEM CREA #64972
K821472
Emd Chemicals, Inc.
Chemistry · 16d
Cleared Jun 03, 1982
ULTRAZYME PLUS CKI, #64978,65027&65028
K821473 · CGS
Emd Chemicals, Inc.
Chemistry · 16d
Cleared Jun 03, 1982
ULTRACHEM URIC ACID AIDH #65047
K821474 · CDO
Emd Chemicals, Inc.
Chemistry · 16d
Cleared Jun 03, 1982
RIA STAT 16
K821494 · JJJ
E. R. Squibb & Sons, Inc.
Chemistry · 16d
Cleared Jun 02, 1982
RADIOIMMUNOASSAY PARATHYROID HORMONE MID
K821131 · CEW
Endocrine-Metabolic Center
Chemistry · 43d
Cleared Jun 02, 1982
BECKMAN LIQUID-STAT AST-UV LIQUID
K821433 · CIT
Beckman Instruments, Inc.
Chemistry · 21d
Cleared Jun 02, 1982
FORMICAL
K821443 · KDX
Lerner Laboratories, Inc.
Chemistry · 19d
Cleared Jun 02, 1982
ULTRACHEM E-GLU, #64976 & 65040
K821461 · CFR
Emd Chemicals, Inc.
Chemistry · 15d
Cleared Jun 02, 1982
ULTRACHEM GLUC-DH, #65048
K821463 · LFR
Emd Chemicals, Inc.
Chemistry · 15d
Cleared Jun 02, 1982
CARDIOZYME PLUS CK-MB, #65045
K821464 · CGS
Emd Chemicals, Inc.
Chemistry · 15d
Cleared Jun 02, 1982
ULTRACHEM URIC ACID AIDH, #65047
K821465 · CDO
Emd Chemicals, Inc.
Chemistry · 15d
Cleared Jun 02, 1982
ULTRAZYME PLUS-GT, #64959 & 65032
K821468 · JPZ
Emd Chemicals, Inc.
Chemistry · 15d
Cleared Jun 02, 1982
ULTRACHEM GLUC-DH, #65048
K821469 · LFR
Emd Chemicals, Inc.
Chemistry · 15d
Cleared Jun 02, 1982
ULTRACHEM E-GLU #64976 & 65040
K821470 · CFR
Emd Chemicals, Inc.
Chemistry · 15d
Cleared Jun 02, 1982
ULTRAZYME PLUS ALP #64962,65029&65030
K821471 · CJE
Emd Chemicals, Inc.
Chemistry · 15d
Cleared Jun 01, 1982
SPAC T4 RIA TEST KIT
K820725 · CDX
Mallinckrodt Critical Care
Chemistry · 76d
Cleared Jun 01, 1982
FREE T4 RADIOIMMUNOASSAY KIT
K821241 · CEC
Bioclinical Group
Chemistry · 33d
Cleared Jun 01, 1982
MR 600 MICROPLATE READER
K821439 · JJQ
Dynatech Corp.
Chemistry · 19d
Cleared Jun 01, 1982
ENZYMATIC CHOLESTERAL OXIDASE #650550
K821441 · CHH
Emd Chemicals, Inc.
Chemistry · 19d
Cleared Jun 01, 1982
ULTRAZYME PLUS CK-I, #64978,65027&65028
K821460 · CGS
Emd Chemicals, Inc.
Chemistry · 14d