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
4897–4920 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Apr 24, 1996
SERUM VOLATILES CONTROL LEVEL 1 & 2
K955691 · JJY
Clinical Controls, Inc.
Chemistry · 132d
Cleared Apr 23, 1996
MINICLINIC OVULATION PREDICTOR
K960233 · CEP
Vanguard Biomedical Corp.
Chemistry · 97d
Cleared Apr 23, 1996
LIQUID CARDIAC MARKER 1,2,3 ASSAYED
K960246 · JJT
Ciba Corning Diagnostics Corp.
Chemistry · 98d
Cleared Apr 23, 1996
IMMUNOLOGY CONTROL
K960824 · JJY
Medical Analysis Systems, Inc.
Chemistry · 54d
Cleared Apr 23, 1996
DSL ACTIVE NON-EXTRACTION IGF-I IRMA
K961172 · CFL
Diagnostic Systems Laboratories, Inc.
Chemistry · 29d
Cleared Apr 23, 1996
OPUS T3 CONTROLS
K961206 · JJX
Behring Diagnostics, Inc.
Chemistry · 27d
Cleared Apr 17, 1996
WHATMAN BODY FLUID COLLECTION PAPER:WHATMAN BFC180
K932661 · PJC
Whatman Specialty Products, Inc.
Chemistry · 1050d
Cleared Apr 17, 1996
ACCU-CHEK INSTANT PLUS G-C/DM BLOOD GLUCOSE MONITORING SYSTEM
K944459 · CGA
Boehringer Mannheim Corp.
Chemistry · 583d
Cleared Apr 15, 1996
THYROCHEK ONE-STEP RAPID TSH ASSAY
K960195 · JLW
Franklin Diagnostics, Inc.
Chemistry · 90d
Cleared Apr 08, 1996
CARBON DIOXIDE - DST
K960035 · KHS
Trace America, Inc.
Chemistry · 96d
Cleared Apr 05, 1996
TRIGLYCERIDES LIQUID STABLE INCORPORATING DYNAMIC STABILISATION TECHNOLOGY
K953971 · CDT
Trace America, Inc.
Chemistry · 226d
Cleared Apr 05, 1996
ACTIVE LH IRMA
K961109 · CEP
Diagnostic Systems Laboratories, Inc.
Chemistry · 16d
Cleared Apr 04, 1996
HICHEM GLUCOSE/HK REAGENT KIT
K960084 · CFR
Hi Chem, Inc.
Chemistry · 84d
Cleared Apr 03, 1996
ENA-C-T ASSAYED TOTAL CHOLESTEROL CONTROLS
K960378 · JJX
Actimed Laboratories, Inc.
Chemistry · 68d
Cleared Apr 03, 1996
LIPID CONTROL
K960862 · JJY
Medical Analysis Systems, Inc.
Chemistry · 33d
Cleared Apr 01, 1996
TRUE TRIGLYCERIDE
K960088 · CDT
Diagnostic Chemicals , Ltd.
Chemistry · 81d
Cleared Apr 01, 1996
UNIMARK MIDSTREAM PREGNANCY TEST STICK
K960174 · LCX
Biotech Atlantic, Inc.
Chemistry · 76d
Cleared Mar 29, 1996
HICHEM BUN/UREA REAGENT KIT
K960115 · CDQ
Elan Pharma, Inc.
Chemistry · 78d
Cleared Mar 29, 1996
VACUTAINER BRAND PLUS SERUM & SST TUBES
K960250 · JKA
Becton Dickinson Vacutainer Systems
Chemistry · 73d
Cleared Mar 29, 1996
ORGENTEC MICRO-ALBUMIN PIN EIA ASSAY
K960274 · JIR
Orgentec
Chemistry · 70d
Cleared Mar 29, 1996
ACCESS FREE T3 ASSAY
K960913 · CDP
Bio-Rad Laboratories, Inc.
Chemistry · 23d
Cleared Mar 28, 1996
ACTIVE CROSSLAPS ELISA
K960171 · JMM
Diagnostic Systems Laboratories, Inc.
Chemistry · 72d
Cleared Mar 22, 1996
BEST PREGNANCY TEST
K953606 · LCX
Ameritek, Inc.
Chemistry · 233d
Cleared Mar 22, 1996
DOCUMENT TDM ULTRA ASSAYED CONTROL
K960244 · DIF
Casco Standards
Chemistry · 66d