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
9313–9336 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Aug 05, 1985
TDX CORTISOL
K852927 · JFT
Abbott Laboratories
Chemistry · 27d
Cleared Aug 02, 1985
REPLACEMENT REAGENTS FOR SMAC II SYSTEMS
K852306 · JJC
Methodist Hospital of Memphis
Chemistry · 65d
Cleared Aug 02, 1985
DC LIQUITROL LEVEL 1 & 2
K852753 · JJY
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 35d
Cleared Aug 02, 1985
SOPHEIA DHEA-SO4 EIA KIT
K852847 · JKC
Diagnostic Products Corp.
Chemistry · 28d
Cleared Aug 02, 1985
CORTISOL SYSTEM BY EIA
K852939 · CGR
American Bioclinical, Inc.
Chemistry · 23d
Cleared Aug 02, 1985
BIOVATION MAX DATA MANAGEMENT SYSTEM
K853026 · JQP
Biovation, Inc.
Chemistry · 15d
Cleared Aug 02, 1985
ALBUMIN REAGENT FOR ASTRA 8 AUTO STAT/ROUT ANALYZE
K853049 · CIX
Simmler, Inc.
Chemistry · 14d
Cleared Aug 02, 1985
CALCIUM REAGENT FOR ASTRA 8 AUTOM STAT/ROUT/ANALYZ
K853050 · CIC
Simmler, Inc.
Chemistry · 14d
Cleared Aug 02, 1985
UREASE & GLUTAMATE DEHYDROGENASE, UREA NITROGEN
K853102 · CDQ
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 10d
Cleared Aug 01, 1985
ACCU-CHEK II
K851456 · CGA
Boehringer Mannheim Corp.
Chemistry · 112d
Cleared Jul 29, 1985
COLOR OVULATION TEST
K851445 · CEP
Nms Pharmaceuticals, Inc.
Chemistry · 109d
Cleared Jul 29, 1985
QUIDEL QUEST OVULATION TEST
K852146 · CEP
Quidel Corp.
Chemistry · 74d
Cleared Jul 23, 1985
AMRESCO FLOW PAC ALKALINE PHOSPHATASE BUFFER CONCE
K852752 · CJE
American Research Products Co.
Chemistry · 25d
Cleared Jul 23, 1985
CHOLESTEROL METHOD
K852863 · CHH
Catachem, Inc.
Chemistry · 15d
Cleared Jul 22, 1985
CEDIA TOTAL T4 ASSAY
K852164 · KLI
Microgenics Corp.
Chemistry · 63d
Cleared Jul 22, 1985
QUICK-CHEM CALIBRATION SET
K852260 · JIW
Seragen Diagnostics, Inc.
Chemistry · 59d
Cleared Jul 22, 1985
UROL-GUANT
K852295 · JJW
Dimension Diagnostics
Chemistry · 54d
Cleared Jul 22, 1985
TDX REA TRIGLYCERIDES
K852556 · JGW
Abbott Laboratories
Chemistry · 35d
Cleared Jul 22, 1985
AMERLEX-M B-HUMAN CHORIONIC GONADTROPIN RADIOI KIT
K852675 · JHI
Amersham Corp.
Chemistry · 28d
Cleared Jul 22, 1985
IL SYSTEM 1304 & 1306, PH/BLOOD GAS ANALYZERS
K852676 · CHL
Allied Instrumentation Laboratory
Chemistry · 28d
Cleared Jul 22, 1985
SGOT/ALT REAGENT
K852783 · CIT
Advanced Biomedical Methods, Inc.
Chemistry · 21d
Cleared Jul 22, 1985
ALKALINE PHOSPHATASE
K852784 · CJE
Advanced Biomedical Methods, Inc.
Chemistry · 21d
Cleared Jul 22, 1985
AMRESCO FLOW PAC TOTAL PROTEIN BIURET & BLANK CONC
K852844 · CEK
American Research Products Co.
Chemistry · 17d
Cleared Jul 16, 1985
ISOGEL AGAROSE
K841407 · JJN
Fmc Corp.
Chemistry · 468d