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
6817–6840 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Sep 10, 1990
ABBOTT VISION LYTE (TM) SODIUM
K903188 · JGS
Abbott Laboratories
Chemistry · 53d
Cleared Sep 10, 1990
TDX FREE T4 CALCULATION
K903383 · CEC
Abbott Laboratories
Chemistry · 45d
Cleared Sep 10, 1990
IMX FREE T4 CALCULATION
K903384 · CEC
Abbott Laboratories
Chemistry · 45d
Cleared Sep 10, 1990
DSL ANDROSTANEDIOL GLUCURONIDE (DSL #6000)
K903616 · JKC
Diagnostic Systems Laboratories, Inc.
Chemistry · 33d
Cleared Sep 07, 1990
C3C AND C4 RID KITS
K902382 · CZW
The Binding Site, Ltd.
Chemistry · 100d
Cleared Sep 07, 1990
ACID PHOSPHOTASE REAGENT TEST AND KIT
K902543 · CKB
Crestat Diagnostics, Inc.
Chemistry · 93d
Cleared Sep 07, 1990
ROCHE COBAS READY CREATININE REAGENT
K902561 · CGX
Roche Diagnostic Systems, Inc.
Chemistry · 88d
Cleared Sep 07, 1990
ABBOTT IMX FREE T4
K902834 · CEC
Abbott Laboratories
Chemistry · 71d
Cleared Sep 07, 1990
MILENIA (TM) AMPHETAMINE
K902979 · DKZ
Diagnostic Products Corp.
Chemistry · 67d
Cleared Sep 07, 1990
ROCHE COBAS READY AMYLASE REAGENT
K903309 · JFJ
Roche Diagnostic Systems, Inc.
Chemistry · 45d
Cleared Sep 07, 1990
CHALLENGE(TM) BRAND LIQ MULTI-ANALYTE LINEAR CONTR
K903310 · JJY
Medical Analysis Systems, Inc.
Chemistry · 45d
Cleared Sep 07, 1990
NOVAPATH TSH ENZYME IMMUNOASSAY
K903311 · JLW
Bio-Rad
Chemistry · 45d
Cleared Sep 07, 1990
UREA NITROGEN TEST
K903334 · CDQ
Em Diagnostic Systems, Inc.
Chemistry · 44d
Cleared Sep 07, 1990
KENLOR THERAPEUTIC DRUG MONITORING (TDM) CONTROL
K903338 · JJY
Kenlor Industries, Inc.
Chemistry · 44d
Cleared Sep 07, 1990
AFFINITY HLH TEST SYSTEM
K903407 · JJY
Bd Becton Dickinson Vacutainer...
Chemistry · 38d
Cleared Sep 07, 1990
IMX FREE T3 CALCULATION
K903432 · CDP
Abbott Laboratories
Chemistry · 38d
Cleared Sep 07, 1990
LABELLING CHANGES TO IMPRES-MB-X
K903508 · JHW
Intl. Immunoassay Laboratories, Inc.
Chemistry · 38d
Cleared Sep 07, 1990
SYNERMED TOTAL PROTEIN REAGENT KIT
K903511 · CEK
Synermed, Inc.
Chemistry · 35d
Cleared Sep 07, 1990
REFLOTRON CREATININE TEST TABS
K903573 · JFY
Boehringer Mannheim Corp.
Chemistry · 31d
Cleared Sep 07, 1990
AIA-PACK IRI
K903628 · CFP
Tosoh Corp.
Chemistry · 28d
Cleared Aug 29, 1990
INTERJECTOR BLOOD COLLECTION DEVICE
K901756 · JKA
Bowman/Vector, Inc.
Chemistry · 134d
Cleared Aug 29, 1990
IMMUNOCORP LH IRMA COATED TUBE
K903052 · CEP
Immunocorp Sciences, Inc.
Chemistry · 49d
Cleared Aug 29, 1990
STAT TEST HDL/CHOLESTEROL TEST KIT
K903094 · LBR
Diagnostic Resources, Inc.
Chemistry · 47d
Cleared Aug 29, 1990
TECHNICON CHEM I SYSTEM MAGNESIUM METHOD
K903306 · JGJ
Technicon Instruments Corp.
Chemistry · 36d