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
9241–9264 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Oct 15, 1985
PANTEX DIRECT TESTOSTERONE COATED TUBE RADIOIMMUNO
K853865 · CDZ
Pantex, Div. Bio-Analysis, Inc.
Chemistry · 28d
Cleared Oct 15, 1985
PANTEX DIRECT ESTRADIOL COATED TUBE RADIOIMMUNOASS
K853866 · CHP
Pantex, Div. Bio-Analysis, Inc.
Chemistry · 28d
Cleared Oct 15, 1985
AMRESCO FLOW PAC CREATININE COLOR REAGENT 2310 &
K853888 · CGX
American Research Products Co.
Chemistry · 26d
Cleared Oct 15, 1985
TDX AMYLASE
K853978 · CIX
Abbott Laboratories
Chemistry · 19d
Cleared Oct 08, 1985
CANTROL URINE DIPSTICK CONTROL TWO LEVELS
K853603 · JJW
Canyon Diagnostics, Inc.
Chemistry · 41d
Cleared Oct 04, 1985
VENTREZYME T3 IMMUNOASSAY T3
K853703 · CDP
Vxr, Inc.
Chemistry · 30d
Cleared Oct 04, 1985
C-TERMINAL PTH RIA KIT
K853784 · CEW
Diagnostic Systems Laboratories, Inc.
Chemistry · 25d
Cleared Oct 04, 1985
LYTENING 1
K853832 · JGS
Amdev, Inc.
Chemistry · 21d
Cleared Oct 04, 1985
PANTEX DIRECT DHEA-S COATED TUBE RADIOIMMUNOASSAY
K853867 · JKC
Pantex, Div. Bio-Analysis, Inc.
Chemistry · 17d
Cleared Oct 04, 1985
QCA ENZYMATIC CHOLESTEROL
K853871 · CHH
Bd Becton Dickinson Vacutainer...
Chemistry · 17d
Cleared Oct 04, 1985
LIQUI-SERA CHEMISTRY CONTROLS (COMPREHENSIVE)
K853906 · JJY
Biodiagnostic Intl
Chemistry · 14d
Cleared Oct 04, 1985
QUANTIMETRIX HUMAN SERUM CHEMISTRY CONTROL
K853931 · JJY
Quantimetrix Corp.
Chemistry · 10d
Cleared Oct 04, 1985
QUANTIMETRIX HUMAN SERUM THERAPEUTIC DRUG CONTROL
K853933 · DIF
Quantimetrix Corp.
Chemistry · 10d
Cleared Oct 03, 1985
BETA SCAN TRENDS METER
K851822 · CGA
Orange Medical Instruments, Inc.
Chemistry · 160d
Cleared Oct 03, 1985
PHASE II B-12/FOLATE KIT
K853224 · CDD
Medical & Scientific Designs, Inc.
Chemistry · 63d
Cleared Oct 03, 1985
PREGNA/TEST
K853269 · LCX
Modern Diagnostics, Inc.
Chemistry · 59d
Cleared Oct 03, 1985
TECHNICON CHEM 1 SYS ANALYTES MAGNESIUM GGT, URIC
K853853 · JGJ
Technicon Instruments Corp.
Chemistry · 17d
Cleared Oct 02, 1985
ALLEGRO TM HS-TSH IMMUNOASSAY SYSTEM
K853717 · JLW
Nichols Institute Diagnostics
Chemistry · 27d
Cleared Oct 01, 1985
EDC/TITAN GELISO-DOT TOTAL LDH ISOENZYME PROCEDURE
K852391 · CFH
Helena Laboratories
Chemistry · 118d
Cleared Oct 01, 1985
BETA-HCG MICROTITER PREGNANCY TEST
K853258 · JHI
Modern Diagnostics, Inc.
Chemistry · 60d
Cleared Oct 01, 1985
MULTIPURPOSE IMMUNOCHEMISTRY SYS-LA-2000
K853391 · JJE
Eiken Chemical Co., Inc.
Chemistry · 49d
Cleared Oct 01, 1985
VENTRESCREEN HCG URINE
K853748 · JHI
Vxr, Inc.
Chemistry · 22d
Cleared Sep 30, 1985
MR 650 MICROPLATE READER(CAT. NO. 011-973-0500)
K852411 · JJQ
Dynatech Laboratories, Inc.
Chemistry · 116d
Cleared Sep 30, 1985
LKB 4057 ULTROSPEC II E
K852538 · JJQ
Lkb Instruments, Inc.
Chemistry · 144d