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
10945–10968 of 13,224
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Jul 13, 1982
ULTRACHEM TRI-ES
K821875 · CDT
Harleco Diagnostics
Chemistry · 18d
Cleared Jul 13, 1982
ULTRAZYME PLUS GOT
K821876 · CIT
Harleco Diagnostics
Chemistry · 18d
Cleared Jul 13, 1982
REF. ELECTRODE SOL'N.
K821885 · JIX
Avl Scientific Corp.
Chemistry · 18d
Cleared Jul 13, 1982
PHILLIPS RADIATION MEASURING INSTRUMENT
K821892 · JJJ
Long Island Scientific
Chemistry · 15d
Cleared Jul 08, 1982
LEVEL I CONTROL SERUM
K821557 · JJY
Irvine Scientific
Chemistry · 44d
Cleared Jul 08, 1982
COAT-A-COUNT INSULIN KIT
K821861 · CFP
Diagnostic Products Corp.
Chemistry · 14d
Cleared Jul 08, 1982
ULTRACHEM E-GLU
K821868 · CFR
Harleco Diagnostics
Chemistry · 13d
Cleared Jul 06, 1982
CLINI-TEK SEMI-AUTOMATED URINALYSIS SYST
K821738 · KQO
Miles Laboratories, Inc.
Chemistry · 22d
Cleared Jul 06, 1982
QUANTICOAT 125 I-THEOPHYLLINE RADIOIMM.
K821862 · LCA
Kallestad Laboratories, Inc.
Chemistry · 12d
Cleared Jul 06, 1982
ULTRACHEM GLUC-DH
K821867 · LFR
Harleco Diagnostics
Chemistry · 11d
Cleared Jul 02, 1982
LEVEL II CONTROL SERUM
K821558 · JJX
Irvine Scientific
Chemistry · 38d
Cleared Jul 02, 1982
URICACID
K821741 · KNK
Biodynamics Corp.
Chemistry · 18d
Cleared Jul 02, 1982
POSITIVE & NEGATIVE HCG URINE CONTROLS
K821742 · JJX
Armkel, LLC
Chemistry · 18d
Cleared Jul 02, 1982
NOVA V FLUIDS PACK & EXTERNAL STANDARDS
K821794 · JIX
Shaban Mfg. Co.
Chemistry · 14d
Cleared Jul 02, 1982
PYRIDOXAL-5-PHOSPHATE STRIPES
K821805 · CKA
Boehringer Mannheim Corp.
Chemistry · 15d
Cleared Jul 02, 1982
AMERIFLOUR FLUOROMETER
K821807 · JQP
American Diagnostic Corp.
Chemistry · 15d
Cleared Jul 02, 1982
125I DIGOXIN RADIOIMMUNOASSAY KIT
K821811 · DPB
Cambridge Medical Technology
Chemistry · 14d
Cleared Jul 02, 1982
BECKMAN URIC ACID REAGENT
K821812 · KNK
Beckman Instruments, Inc.
Chemistry · 14d
Cleared Jul 02, 1982
BECKMAN URIC ACID STANDARD
K821813 · JIS
Beckman Instruments, Inc.
Chemistry · 14d
Cleared Jul 02, 1982
MODEL 1020 NA/K ANALYZER
K821822 · CEM
Thermo Orion
Chemistry · 10d
Cleared Jul 02, 1982
DIAGNOSTICS HDL CHOLESTEROL PRECIPITANT
K821852
Boehringer Mannheim Corp.
Chemistry · 9d
Cleared Jun 25, 1982
ULTRACHEM E-GLU #64976&65040
K821475 · CFR
Emd Chemicals, Inc.
Chemistry · 38d
Cleared Jun 25, 1982
ZETAPHASE T3 UPTAKE DIAGNOSTIC KIT
K821553 · KHQ
Amf Biological and Diagnostics Co.
Chemistry · 31d
Cleared Jun 25, 1982
ZETAPHASE T4 RADIOIMMUNOASSAY DIAG. KIT
K821554 · CDX
Amf Biological and Diagnostics Co.
Chemistry · 31d