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
8881–8904 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Jun 27, 1986
TOTAL BILIRUBIN TEST KIT
K861998 · CIG
Ciba Corning Diagnostics Corp.
Chemistry · 35d
Cleared Jun 27, 1986
DOUBLE ANTIBODY COCAINE METABOLITE RIA KIT
K862218 · KLN
Diagnostic Products Corp.
Chemistry · 16d
Cleared Jun 27, 1986
TSH IRMA KIT
K862249 · JLW
Pacific Biotech, Inc.
Chemistry · 15d
Cleared Jun 25, 1986
DOUBLE ANTIBODY CALCITONIN RIA KIT
K861274 · JKR
Diagnostic Products Corp.
Chemistry · 79d
Cleared Jun 25, 1986
ALT-30, 60 AND 100
K861366 · CKA
Dimension Diagnostics
Chemistry · 75d
Cleared Jun 25, 1986
DIRECT BILIRUBIN PROCEDURE
K861671 · CIG
Data Medical Associates, Inc.
Chemistry · 56d
Cleared Jun 25, 1986
ALT (SGPT) REAGENT SET (UV RATE)
K862209 · CKA
Sterling Diagnostics, Inc.
Chemistry · 15d
Cleared Jun 24, 1986
DELFIA (TM) HFSH KIT
K862043 · CGJ
Lkb Instruments, Inc.
Chemistry · 27d
Cleared Jun 19, 1986
TERUMO SENSIBEAD EIA TSH KIT
K861573 · JLW
Terumo Medical Corp.
Chemistry · 52d
Cleared Jun 19, 1986
IMMPULSE FERRITIN ASSAY REAGENT
K862014 · DBF
Sclavo, Inc.
Chemistry · 22d
Cleared Jun 19, 1986
SUDS(HCG)CONTROL SET (URINE&SERUM) & HCG REF.SERUM
K862048 · DQX
Murex Corp.
Chemistry · 21d
Cleared Jun 17, 1986
DELFIA (TM) HUMAN PROLACTIN
K861542 · CFT
Lkb Instruments, Inc.
Chemistry · 54d
Cleared Jun 17, 1986
VISION TOTAL PROTEIN
K861798 · CEK
Abbott Laboratories
Chemistry · 39d
Cleared Jun 17, 1986
MULTI-4 CO-OXIMETER CONTROL
K861901 · JJY
Allied Instrumentation Laboratory
Chemistry · 32d
Cleared Jun 17, 1986
VISION ALBUMIN
K862138 · CJW
Abbott Laboratories
Chemistry · 13d
Cleared Jun 17, 1986
QUIDEL BETA STICK PREGNANCY TEST (MODIFICATION)
K862207 · LCX
Quidel Corp.
Chemistry · 7d
Cleared Jun 16, 1986
DIRECT
K852960 · CGA
University of Wisconsin
Chemistry · 339d
Cleared Jun 16, 1986
HYDROXYBUTYRATE DEHYDROGENASE (HBD) REAGENT SET
K861855 · JKF
Sterling Diagnostics, Inc.
Chemistry · 33d
Cleared Jun 16, 1986
SIMULTRAC NEONATAL T4(57CO)/TSH(125I) RADIOIMMUNO.
K861920 · JLW
Bd Becton Dickinson Vacutainer...
Chemistry · 28d
Cleared Jun 16, 1986
PTK PLUS. HOME PREGNANCY TEST
K861946 · LCX
Healthcheck Corp.
Chemistry · 27d
Cleared Jun 13, 1986
BIOTEL (TM)/ DIABETES
K855239 · JIL
American Diagnostic Corp.
Chemistry · 164d
Cleared Jun 13, 1986
SYVA SOLID PHASE COLUMNS SYSTEM II
K861392 · KZR
Syva Co.
Chemistry · 60d
Cleared Jun 13, 1986
DOCUMENT ENZYME LINEARITY TEST SETS
K861506 · JJT
Casco Standards
Chemistry · 51d
Cleared Jun 13, 1986
ALBUMIN PROCEDURE
K861654 · CIX
Data Medical Associates, Inc.
Chemistry · 44d