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
9409–9432 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared May 30, 1985
CK-NAC REAGENT
K852000 · CGS
Alpkem Corp.
Chemistry · 23d
Cleared May 30, 1985
ALB BCG REAGENT
K852007 · CIX
Alpkem Corp.
Chemistry · 23d
Cleared May 30, 1985
T-BIL REAGENT, D-BIL REAGENT, SODIUM NITRITE & SUL
K852008 · CIG
Alpkem Corp.
Chemistry · 23d
Cleared May 30, 1985
T-CHO REAGENT
K852009 · CHH
Alpkem Corp.
Chemistry · 23d
Cleared May 30, 1985
TGL REAGENT
K852010 · CDT
Alpkem Corp.
Chemistry · 23d
Cleared May 29, 1985
UN(UREASE)REAGENT UN(A-KETO)REAGENT
K851991 · KNK
Alpkem Corp.
Chemistry · 22d
Cleared May 29, 1985
GLU(GOD) REAGENT
K851992 · CGA
Alpkem Corp.
Chemistry · 22d
Cleared May 29, 1985
UA(URICASE) REAGENT
K852004 · KNK
Alpkem Corp.
Chemistry · 22d
Cleared May 24, 1985
OB-PH - PH TEST PAPER
K850858 · LNW
Uro Pharmaceuticals, Inc.
Chemistry · 84d
Cleared May 24, 1985
AMRESCO FLOW PAC SMA PHOSPHATE BUFFER CONCENTRATE
K851923 · CKA
Amresco, Inc.
Chemistry · 22d
Cleared May 24, 1985
TDX REA IRON/TIBC
K851930 · JMO
Abbott Laboratories
Chemistry · 22d
Cleared May 24, 1985
VARIAN AASP AUTOMATED SAMPLE PREP. SYSTEM
K851945 · KZR
Varian Assoc., Inc.
Chemistry · 21d
Cleared May 24, 1985
LKB-WALLAC 1230 ARCUS FLUOROMETER
K851984 · KHO
Lkb Instruments, Inc.
Chemistry · 17d
Cleared May 21, 1985
PHADEBAS RAST PHADEZYM RAST ALLERTUBES
K851273 · DHB
Pharmacia, Inc.
Chemistry · 50d
Cleared May 21, 1985
HA-1000 & HA-500 HYDROXYLAPATITE-MODIFICATION
K851367 · DZE
Orthomatrix, Inc.
Chemistry · 46d
Cleared May 20, 1985
ELVI 655 FLAME PHOTOMETER
K843375 · JJO
Logos Scientific, Inc.
Chemistry · 265d
Cleared May 20, 1985
FISHER DIAGNOSTICS KDA CALIBRATOR I
K851150 · JIX
Fisher Scientific Co., LLC
Chemistry · 60d
Cleared May 20, 1985
FISHER DIAGNOSTICS KDA CALIBRATOR II
K851151 · JIX
Fisher Scientific Co., LLC
Chemistry · 60d
Cleared May 20, 1985
ULTRA-VIOLET BUN REAGENT KIT
K851513 · CDQ
Bio-Analytics Laboratories, Inc.
Chemistry · 35d
Cleared May 20, 1985
ULTRA-VIOLET GLUCOSE REAGENT
K851514 · CFA
Bio-Analytics Laboratories, Inc.
Chemistry · 35d
Cleared May 20, 1985
TRIGLYCERIDE(TRINDER) PROCEDURE
K851538 · CDT
Data Medical Associates, Inc.
Chemistry · 34d
Cleared May 20, 1985
TDX TOTAL T3
K851676 · CDP
Abbott Laboratories
Chemistry · 27d
Cleared May 20, 1985
CREATINE LIQUID STABLE REAGENT SET
K851849 · CGX
Medical Analysis Systems, Inc.
Chemistry · 24d
Cleared May 20, 1985
AMRESCO FLOW PAC SMA PHOSPHATE BUFFER CONCENTRATE
K851865 · CIT
Amresco, Inc.
Chemistry · 21d