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
7537–7560 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Feb 17, 1989
MICROLITE CAMERA LUMINOMETER CL 1050 (0119010000)
K884782 · JJQ
Dynatech Laboratories, Inc.
Chemistry · 94d
Cleared Feb 17, 1989
CHOLESTEROL TEST ITEM NUMBER: SR1011
K885023 · CHH
Em Diagnostic Systems, Inc.
Chemistry · 74d
Cleared Feb 17, 1989
ALKALINE PHOSPHATASE ISOENZYME SYSTEM
K885024 · CIN
Ciba Corning Diagnostics Corp.
Chemistry · 74d
Cleared Feb 17, 1989
EMIT THYROXINE ASSAY
K885141 · KLI
Syva Co.
Chemistry · 64d
Cleared Feb 17, 1989
AMYLASE SR LIQUID STABLE REAGENT SET
K885176 · JFJ
Medical Analysis Systems, Inc.
Chemistry · 65d
Cleared Feb 17, 1989
TECHNICON AXON(TM) SYSTEM
K885226 · JJE
Technicon Instruments Corp.
Chemistry · 59d
Cleared Feb 17, 1989
ACA THYROXINE (T4 E) METHOD
K885258 · KLI
The DU Pont Co.
Chemistry · 56d
Cleared Feb 17, 1989
ACA THYRONINE UPTAKE (TU E) METHOD
K885259 · KHQ
The DU Pont Co.
Chemistry · 56d
Cleared Feb 17, 1989
BIOTROL CHLORIDE
K890015 · CHJ
Biotrol, USA, Inc.
Chemistry · 45d
Cleared Feb 17, 1989
HDL CHOLESTEROL REAGENT (PTA/MGCL2)
K890023 · LBR
Sigma Diagnostics, Inc.
Chemistry · 44d
Cleared Feb 17, 1989
BICARBONATE TEST ITEM NUMBER: SR1006
K890305 · KHS
Em Diagnostic Systems, Inc.
Chemistry · 25d
Cleared Feb 17, 1989
RFA/2 RAPID FLOW ANALYZER W/COMPUTER
K890332 · JJC
Alpkem Corp.
Chemistry · 25d
Cleared Feb 17, 1989
ALBUMIN REAGENT
K890333 · EIX
Alpkem Corp.
Chemistry · 25d
Cleared Feb 17, 1989
SODIUM HYDROXIDE SOLUTION, CREATININE REAG./DILU.
K890335 · CGE
Alpkem Corp.
Chemistry · 25d
Cleared Feb 14, 1989
AIR DISPLACEMENT PIPETTE
K885340 · JQW
Ulster Scientific, Inc.
Chemistry · 48d
Cleared Feb 10, 1989
CREATINE KINASE-MB TEST (CK-MK) ITEM NUMBER 65673
K884547 · CGS
Em Diagnostic Systems, Inc.
Chemistry · 102d
Cleared Feb 10, 1989
IL PHOENIX, MODEL 900, CHEMISTRY/ELECTROLYTE ANALY
K884771 · JFP
Instrumentation Laboratory CO
Chemistry · 88d
Cleared Feb 10, 1989
BIOTROL ALBUMIN
K885094 · CIX
Biotrol, USA, Inc.
Chemistry · 63d
Cleared Feb 10, 1989
CLINISTAT TRIGLYCERIDES REAGENT TEST
K885134 · JGY
Heraeus Kulzer, Inc.
Chemistry · 60d
Cleared Feb 10, 1989
VENTREX COATED TUBE HIGH SENSITIVITY TSH
K885157 · JLW
Ventrex Laboratories, Inc.
Chemistry · 59d
Cleared Feb 10, 1989
HDL CHOLESTEROL TEST
K885265 · LBR
Em Diagnostic Systems, Inc.
Chemistry · 50d
Cleared Feb 10, 1989
IMX FOLLICLE STIMULATING HORMONE (FSH)
K890135 · CGJ
Abbott Laboratories
Chemistry · 28d
Cleared Feb 10, 1989
IRON REAGENTS ITEM NUMBER: SR1017
K890304 · JIY
Em Diagnostic Systems, Inc.
Chemistry · 18d
Cleared Feb 08, 1989
AMERLITE FT3 ASSAY, LAN.0007/2007 240/144 TEST KIT
K885195 · CDP
Amersham Corp.
Chemistry · 54d