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
8689–8712 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Oct 03, 1986
BEHRING RAPIMAT II
K861263 · JJQ
Behring Diagnostics, Inc.
Chemistry · 182d
Cleared Oct 03, 1986
LACTATE DEHYDROGENASE(LD) PROCEDURE
K863255 · CFJ
Data Medical Associates, Inc.
Chemistry · 39d
Cleared Oct 03, 1986
GAMMA GLUTAMYL TRANSFERASE PROCEDURE
K863586 · JPZ
Data Medical Associates, Inc.
Chemistry · 18d
Cleared Oct 03, 1986
CREATINE PHOSPHOKINASE(CK) PROCEDURE
K863587 · CGS
Data Medical Associates, Inc.
Chemistry · 18d
Cleared Oct 03, 1986
TDX(R) AMYLASE II
K863622 · JFJ
Abbott Laboratories
Chemistry · 17d
Cleared Oct 03, 1986
CORNING ELISA PLATES
K863789 · LIB
Corning Medical & Scientific
Chemistry · 7d
Cleared Oct 02, 1986
CREATININE PROCEDURE
K863261 · CGX
Data Medical Associates, Inc.
Chemistry · 38d
Cleared Oct 02, 1986
POTASSIUM HYDROXIDE 10% W/V
K863550 · PPM
Reagent Laboratory, Inc.
Chemistry · 20d
Cleared Oct 01, 1986
AMRESCO FLOW PAC UREA NITROGEN REAGENTS #1346
K863425 · CDW
American Research Products Co.
Chemistry · 27d
Cleared Sep 29, 1986
HDL/CHOLESTEROL TEST SYSTEM
K861244 · LBS
Chrometrics Laboratories, Inc.
Chemistry · 180d
Cleared Sep 29, 1986
OLYMPUS AU 5000 FLAME PHOTOMETER MODULE
K862148 · JJO
Olympus Corp.
Chemistry · 117d
Cleared Sep 29, 1986
AMYLASE SR LIQUID STABLE REAGENT SET
K862733 · JFJ
Medical Analysis Systems, Inc.
Chemistry · 73d
Cleared Sep 29, 1986
PREGNASLIDE
K863198 · JHJ
Armkel, LLC
Chemistry · 41d
Cleared Sep 29, 1986
PROLACTIN RIABEAD II DIAGNOSTIC KIT
K863240 · CFT
Abbott Laboratories
Chemistry · 38d
Cleared Sep 29, 1986
CHOLESTEROL PROCEDURE
K863252 · CHH
Data Medical Associates, Inc.
Chemistry · 35d
Cleared Sep 29, 1986
TOTAL PROTEIN PROCEDURE
K863258 · CEK
Data Medical Associates, Inc.
Chemistry · 35d
Cleared Sep 29, 1986
ALKALINE PHOSPHATASE PROCEDURE
K863268 · CJE
Data Medical Associates, Inc.
Chemistry · 35d
Cleared Sep 29, 1986
URIC ACID (URICASE) METHOD-II
K863287 · JHC
Catachem, Inc.
Chemistry · 35d
Cleared Sep 29, 1986
AVL ISE-TROL ELECTROLYTE CONTROL
K863333 · JJR
Avl Scientific Corp.
Chemistry · 32d
Cleared Sep 29, 1986
NOVA II SODIUM/POTASSIUM/LITHIUM ANALYZER
K863438 · JJP
Nova Biomedical Corp.
Chemistry · 24d
Cleared Sep 29, 1986
POTASSIUM TEST
K863486 · CEJ
Sclavo, Inc.
Chemistry · 20d
Cleared Sep 29, 1986
PARAMAX ELECTROLYTE CALIBRATOR
K863489 · JIX
American Dade
Chemistry · 20d
Cleared Sep 29, 1986
EASY-TEST CARBON DIOXIDE (CO2) ITEM #67649/95
K863544 · KHS
Em Diagnostic Systems, Inc.
Chemistry · 17d
Cleared Sep 29, 1986
AMYLASE PROCEDURE
K863588 · JFJ
Data Medical Associates, Inc.
Chemistry · 14d