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
7297–7320 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Sep 05, 1989
EMIT T-UPTAKE ASSAY
K894145 · KHQ
Syva Co.
Chemistry · 83d
Cleared Sep 05, 1989
BUN-BLOOD UREA NITROGEN FOR MANUAL/AUTO APPLICAT
K894173 · CDQ
Catachem, Inc.
Chemistry · 82d
Cleared Sep 05, 1989
RADIOASSAY CONTROLS 31 & 32, ANTI-DSDNA CONTROL
K894329 · JJX
Amersham Corp.
Chemistry · 53d
Cleared Sep 05, 1989
ABBOTT TESTPACK PLUS HCG URINE
K894408 · JHI
Abbott Laboratories
Chemistry · 50d
Cleared Sep 05, 1989
GEMTAB SYSTEM
K894503 · JJQ
Pharmacia Eni Diagnostics, Inc.
Chemistry · 48d
Cleared Aug 31, 1989
EMDS CREATINE KINASE ITEM NIMBER 65411
K893691 · CGS
Diagnostic Systems
Chemistry · 107d
Cleared Aug 31, 1989
MODIFIED MODEL 570 CLINICAL CHEMISTRY ANALYZER
K893838 · JQP
Ciba Corning Diagnostics Corp.
Chemistry · 99d
Cleared Aug 31, 1989
EMDS TOTAL PROTEIN (TP), ITEM NUMBER 65420
K893915 · CEK
Em Diagnostic Systems, Inc.
Chemistry · 93d
Cleared Aug 31, 1989
QUIKREAD WHOLE BLOOD HDL-CHOLESTEROL TEST KIT
K894057 · LBS
Photec Diagnostics, Inc.
Chemistry · 85d
Cleared Aug 31, 1989
ROCHO ISOMUNE - LD
K894081 · CFE
Roche Diagnostic Systems, Inc.
Chemistry · 84d
Cleared Aug 31, 1989
POSITIVE AND NEGATIVE HCG URINE CONTROLS
K894181 · JJX
Armkel, LLC
Chemistry · 76d
Cleared Aug 31, 1989
PHOSPHORUS TEST ITEM NUMBER 65416
K894288 · CED
Em Diagnostic Systems, Inc.
Chemistry · 69d
Cleared Aug 31, 1989
REP HDL-8 KIT, NO. 3188, REP HDL-16 KIT, NO. 3187
K894366 · LBT
Helena Laboratories
Chemistry · 48d
Cleared Aug 31, 1989
UREA NITROGEN TEST (BUN) ITEM #65408
K894378 · CDQ
Em Diagnostic Systems, Inc.
Chemistry · 45d
Cleared Aug 31, 1989
MAGNESIUM TEST ITEM NUMBER: 65419
K894508 · JGJ
Em Diagnostic Systems, Inc.
Chemistry · 43d
Cleared Aug 31, 1989
DPC-ROBOSTAT(TM)
K894710 · JQW
Diagnostic Products Corp.
Chemistry · 38d
Cleared Aug 28, 1989
STATSPIN MINI-PLASMA
K893613 · JKA
Statspin Technologies
Chemistry · 110d
Cleared Aug 28, 1989
EMDS CHOLESTEROL (CHO), ITEM NUMBER 65410
K893916 · CHH
Em Diagnostic Systems, Inc.
Chemistry · 90d
Cleared Aug 28, 1989
EMDS TRIGLYCERIDE (TRIG), ITEM NUMBER 65421
K893917 · CDT
Em Diagnostic Systems, Inc.
Chemistry · 90d
Cleared Aug 28, 1989
CK-MB/LD-1 CONTROL SYSTEM
K894207 · JJT
Boehringer Mannheim Corp.
Chemistry · 70d
Cleared Aug 28, 1989
URIC ACID TEST ITEM NUMBER 65422
K894287 · KNK
Em Diagnostic Systems, Inc.
Chemistry · 66d
Cleared Aug 25, 1989
AD X(TM) ETHANOL
K890743 · DIC
Abbott Laboratories
Chemistry · 193d
Cleared Aug 21, 1989
EMDS ASPARTATE AMINOTRANSFERASE ITEM NUMBER 65405
K893692 · CIT
Diagnostic Systems
Chemistry · 97d
Cleared Aug 21, 1989
ALBUMIN TEST (ALB) ITEM NUMBER: 65401
K893777 · CIX
Em Diagnostic Systems, Inc.
Chemistry · 91d