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
8833–8856 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Jul 22, 1986
ALLEGRO INTACT PARATHYROID HORMONE IMMUNOASSAY
K861797 · CEW
Nichols Institute Diagnostics
Chemistry · 74d
Cleared Jul 22, 1986
TRIGLYCERIDES
K862033 · CDT
Pointe Scientific, Inc.,
Chemistry · 55d
Cleared Jul 16, 1986
FAST CHOLESTEROL (TOTAL CHOLESTEROL TEST)
K862507 · CHH
Sclavo, Inc.
Chemistry · 15d
Cleared Jul 14, 1986
HEMAFLUOR REAGENT KIT
K860309 · KHO
Helena Laboratories
Chemistry · 167d
Cleared Jul 14, 1986
MICROMEDIC HTSH MONOCLONAL IRMA KIT
K860813 · JLW
Micromedic Systems
Chemistry · 132d
Cleared Jul 14, 1986
ISOPURE LC SYSTEM
K862178 · LDM
The Perkin-Elmer Corp.
Chemistry · 35d
Cleared Jul 11, 1986
SOLID PHASE BOIL DUALCOUNT (DUALCOUNT SPB)
K860815 · CDD
Diagnostic Products Corp.
Chemistry · 129d
Cleared Jul 11, 1986
REFLOTRON URIC ACID
K861831 · KNK
Boehringer Mannheim Corp.
Chemistry · 59d
Cleared Jul 11, 1986
DELFIA (TM) HCG KIT
K862044 · JHJ
Lkb Instruments, Inc.
Chemistry · 44d
Cleared Jul 08, 1986
KING DIAGNOSTICS URIC ACID TEST
K862208 · KNK
King Diagnostics, Inc.
Chemistry · 28d
Cleared Jul 07, 1986
DIRECT ACU-SLIDE TEST
K861212 · JHJ
Cal-Tech Diagnostics, Inc.
Chemistry · 98d
Cleared Jul 07, 1986
TDX REA LACTIC ACID
K861741 · KHP
Abbott Laboratories
Chemistry · 62d
Cleared Jul 07, 1986
V-TREND QC URINE CHEMISTRY CONTROLS LEVEL, I & II
K861756 · JJW
Texas Immunology, Inc.
Chemistry · 62d
Cleared Jul 07, 1986
VANILMANDELIC ACID (VMA) REAGENT SET
K861962 · CDF
Sterling Diagnostics, Inc.
Chemistry · 48d
Cleared Jul 07, 1986
MODIFIED COTROPIN RADIOIMMUNOASSAY KIT
K862180 · CEP
Clinetics Corp.
Chemistry · 28d
Cleared Jul 07, 1986
HBDH (OPTIMIZED) REAGENT
K862319 · JMK
Sigma Chemical Co.
Chemistry · 19d
Cleared Jul 02, 1986
GLUCOMETER M BLOOD GULCOSE METER
K855202 · CGA
Miles Laboratories, Inc.
Chemistry · 188d
Cleared Jul 02, 1986
RAMP PROGESTURINE PDG ASSAY--48 TEST KIT
K860924 · JLS
Monoclonal Antibodies, Inc.
Chemistry · 113d
Cleared Jul 02, 1986
GILFORD UNIQUAL ABNORMAL CONTROL SERUM/ASSAYED
K860999 · JJY
Ciba Corning Diagnostics Corp.
Chemistry · 106d
Cleared Jul 02, 1986
GLUCOMETER II IMPROVED REFLECTANCE PHOTOMETER
K861303 · CGA
Miles Laboratories, Inc.
Chemistry · 86d
Cleared Jul 02, 1986
CLINIFACTS 200 DATA MANAGEMENT SYSTEM
K861778 · JQP
Miles Laboratories, Inc.
Chemistry · 55d
Cleared Jul 02, 1986
V-TREND EIA TSH
K861918 · JLW
V-Tech, Inc.
Chemistry · 44d
Cleared Jul 02, 1986
HYGEIA SCIENCES URINE HCG FLOW THORUGH ASSAY
K862083 · JHJ
Hygeia Sciences
Chemistry · 30d
Cleared Jul 01, 1986
CHOLESTEROL CALIBRATORS
K861314 · JIT
Sigma Diagnostics, Inc.
Chemistry · 84d