FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Chemistry ×
13,237 results
6097–6120 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Sep 22, 1992
SYNERMED 600 NM URIC ACID REAGENT KIT
K923414 · KNK
Synermed, Inc.
Chemistry · 74d
Cleared Sep 22, 1992
SYSTEMATE PHOSPHORUS TEST TECHNICON RA 1000
K923764 · CEO
Em Diagnostic Systems, Inc.
Chemistry · 56d
Cleared Sep 22, 1992
SYSTEMATE URICACID TEST, TECHNICON RA 1000
K923765 · CDO
Em Diagnostic Systems, Inc.
Chemistry · 56d
Cleared Sep 22, 1992
MILES AUTO METH DETERMIN OF URIC ACID IN URINE
K924129 · KNK
Heraeus Kulzer, Inc.
Chemistry · 36d
Cleared Sep 18, 1992
VISTA THYROXINE (T-4) ASSAY -- MODIFICATION
K922433 · KLI
Syva Co.
Chemistry · 155d
Cleared Sep 18, 1992
OLYMPUS LACTATE DEHYDROGENASE REAGENT
K923412 · CFJ
Olympus Corp.
Chemistry · 70d
Cleared Sep 18, 1992
OLYMPUS CREATININE REAGENT
K923526 · CGX
Olympus Corp.
Chemistry · 64d
Cleared Sep 17, 1992
IL TEST ALT, PN 35311
K923623 · CKA
Instrumentation Laboratory CO
Chemistry · 58d
Cleared Sep 15, 1992
ONE TOUCH IIB BLOOD GLUCOSE METER
K922888 · CGA
Lifescan, Inc.
Chemistry · 91d
Cleared Sep 15, 1992
ANI BIOCARD HCG TEST
K923030 · JHI
Ani OY
Chemistry · 84d
Cleared Sep 15, 1992
MILES URINE CALCIUM METHOD
K923034 · CIC
Heraeus Kulzer, Inc.
Chemistry · 88d
Cleared Sep 15, 1992
MILES URINE GLUCOSE METHOD
K923040 · CFR
Heraeus Kulzer, Inc.
Chemistry · 88d
Cleared Sep 15, 1992
IQ IMMUNOCHEMISTRY SISTEM
K923060 · JJE
Becton Dickinson Advanced Diagnostics
Chemistry · 82d
Cleared Sep 09, 1992
DU PONT ACA PLUS IMMUNOASSAY SYSTEM TSH CALIBRATOR
K922698 · JIS
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 97d
Cleared Sep 09, 1992
DU PONT ACA PLUS IMMUNOASSAY SYSTEM TSH METHOD
K922701 · JLW
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 97d
Cleared Sep 09, 1992
SYSTEMATE DIRECT BILIRUBIN TEST TECHNICON RA 1000
K922856 · CIG
Em Diagnostic Systems, Inc.
Chemistry · 86d
Cleared Sep 09, 1992
SYSTAMATE ASPARTATE AMINOTRANSFERASE TEST TECHNICO
K922857 · CIT
Em Diagnostic Systems, Inc.
Chemistry · 86d
Cleared Sep 09, 1992
SYSTEMATE CALCIUM TEST TECHNICON RA 1000
K922953 · CIL
Em Diagnostic Systems, Inc.
Chemistry · 83d
Cleared Sep 09, 1992
MILES URINE UREA NITROGEN METHOD
K923035 · CDQ
Heraeus Kulzer, Inc.
Chemistry · 82d
Cleared Sep 09, 1992
URINE CHLORIDE
K923036 · CHJ
Heraeus Kulzer, Inc.
Chemistry · 82d
Cleared Sep 09, 1992
TOTAL BILIRUBIN CATALOG NO. 65407
K923083 · CIG
Em Diagnostic Systems, Inc.
Chemistry · 76d
Cleared Sep 09, 1992
KING DIAGNOSTICS GAMMA GT REAGENT
K923091 · JPZ
King Diagnostics, Inc.
Chemistry · 76d
Cleared Sep 09, 1992
HCG PREGNANCY ONE STEP TEST STRIP
K923123 · JHI
Tcpi, Inc.
Chemistry · 75d
Cleared Sep 09, 1992
KING DIAGNOSTICS CHOLESTEROL REAGENT
K923128 · CHH
King Diagnostics, Inc.
Chemistry · 75d