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
4033–4056 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Sep 22, 1998
VACUTAINER BRAND BLOOD COLLECTION SYRINGE
K982922 · JKA
Becton Dickinson Vacutainer Systems
Chemistry · 34d
Cleared Sep 22, 1998
ELECSYS CALCHECK MYOGLOBIN
K983166 · JJY
Boehringer Mannheim Corp.
Chemistry · 12d
Cleared Sep 21, 1998
UPRO
K981682 · JGQ
Abbott Laboratories
Chemistry · 131d
Cleared Sep 21, 1998
RAICHEM HDL-CHOLESTEROL DIRECT REAGENT, HDL-CHOLESTEROL CALIBRATOR
K982767 · JIX
Raichem
Chemistry · 46d
Cleared Sep 16, 1998
TBIL
K983133 · CIG
Abbott Laboratories
Chemistry · 8d
Cleared Sep 15, 1998
UBI MAGIWEL PAP (PROSTATIC ACID PHOSPHATASE) EIA QUANTITATVE
K981573 · JFH
United Biotech, Inc.
Chemistry · 134d
Cleared Sep 15, 1998
HDLC PRECIPITATING REAGENT
K982539 · LBS
Ac Biochemicals, Inc.
Chemistry · 56d
Cleared Sep 14, 1998
UB ANALYZER UA-2, REAGENT KIT AND BILIRUBIN CONTROL
K972382 · CIG
Arrows Co., Ltd.
Chemistry · 445d
Cleared Sep 14, 1998
CARBON DIOXIDE-SL ASSAY, CAT # 253-01
K983019 · KHS
Diagnostic Chemicals , Ltd.
Chemistry · 14d
Cleared Sep 11, 1998
LACTATE PRO SYSTEM
K980908 · KHP
Kdk Corp.
Chemistry · 185d
Cleared Sep 11, 1998
RANDOX DIRECT LDL CHOLESTEROL
K982529 · MRR
Randox Laboratories, Ltd.
Chemistry · 53d
Cleared Sep 04, 1998
VISUALINE II (ALSO KNOWN AS SUNLINE) METHADONE
K981314 · DJR
Sun Biomedical Laboratories, Inc.
Chemistry · 147d
Cleared Sep 03, 1998
N-ASSAY GLU-UL
K980883 · CFR
Crestat Diagnostics, Inc.
Chemistry · 178d
Cleared Sep 03, 1998
SAFE-T-FILL CAPILLARY BLOOD COLLECTION SYSTEM
K981973 · JKA
Ram Scientific
Chemistry · 90d
Cleared Sep 03, 1998
ACCU-CHEK ADVANTAGE TEST STRIPS AND ACCU-CHEK ADVANTAGE H TEST STRIPS
K982089 · LFR
Boehringer Mannheim Corp.
Chemistry · 80d
Cleared Sep 03, 1998
SANGUI BIOTECH, INC. CALCITONIN ELISA KIT
K982491 · JKR
Sangui Biotech, Inc.
Chemistry · 48d
Cleared Sep 02, 1998
ACCU-CHEK COMFORT CURVE TEST STRIP
K982002 · LFR
Boehringer Mannheim Corp.
Chemistry · 86d
Cleared Sep 01, 1998
ELECTROLYTE BUFFER A443-325, ELECTROLYTE REFERENCE REAGENT A443-315, CO2...
K982501 · JIX
Alko Diagnostic Corp.
Chemistry · 43d
Cleared Aug 28, 1998
AMY
K981653 · JFJ
Abbott Laboratories
Chemistry · 109d
Cleared Aug 28, 1998
ACCU-CHECK VOICEMATE
K982079 · LFR
Boehringer Mannheim Corp.
Chemistry · 74d
Cleared Aug 26, 1998
ROCHE COBAS INTEGRA ALKALINE PHOSPHATASE IFCC LIQUID REAGENT CASSETTE, ROCHE...
K981897 · CJE
Roche Diagnostic Systems, Inc.
Chemistry · 86d
Cleared Aug 25, 1998
CEDIA RED BLOOD CELL FOLATE REAGENT PACK, CEDIA FOLATE ASSAY AND ELECSYS...
K981931 · CGN
Roche Diagnostics/Boehringer Mannheim...
Chemistry · 84d
Cleared Aug 21, 1998
CARDIAC MARKERS CONTROL (SINGLE USE)-LEVELS, 1,2,3, MODELS NUMBER 175-1,...
K982845 · JJT
More Diagnostics
Chemistry · 9d
Cleared Aug 19, 1998
HICHEM CHOLESTEROL REAGENT KIT
K982469 · CHH
Elan Pharma, Inc.
Chemistry · 35d