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
7393–7416 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Jun 20, 1989
IL1400, BGELECTROLYTE ANALYZER
K890827 · CHL
Instrumentation Laboratory CO
Chemistry · 119d
Cleared Jun 20, 1989
AMRESCO PRODUCT NUMBER 7426
K891923 · CFR
American Research Products Co.
Chemistry · 85d
Cleared Jun 20, 1989
ENZYMATIC UREA NITROGEN REAGENT SET
K892331 · CDQ
American Monitor Corp.
Chemistry · 76d
Cleared Jun 20, 1989
REP(TM) LD-2 STAT KIT, CAT. NO. 3078
K892818 · CFE
Helena Laboratories
Chemistry · 64d
Cleared Jun 20, 1989
AST REAGENT (PROCEDURE NUMBER 158)
K892844 · CIT
Sigma Chemical Co.
Chemistry · 63d
Cleared Jun 20, 1989
SRI LUTEINIZING HORMONE IMMUNOENZYMETRIC ASSAY
K893605 · CEP
Serono-Baker Diagnostics, Inc.
Chemistry · 41d
Cleared Jun 19, 1989
AMRESCO UREA NITROGEN (BUN) REAGENTS, PROD # 7123
K891912 · CDQ
American Research Products Co.
Chemistry · 84d
Cleared Jun 19, 1989
BIOSTIX (TM)HCG--SIMPLE PREGNANCY TEST
K892654 · DHA
Princeton Biomedix
Chemistry · 67d
Cleared Jun 19, 1989
DIRECT BILIRUBIN FOR MANUAL OR AUTOMATED APPLI.
K892905 · CIG
Catachem, Inc.
Chemistry · 60d
Cleared Jun 19, 1989
REP SPE-8 KIT, CAT.# 3172/REP SPE-16 KIT CAT.#3171
K893211 · CEF
Helena Laboratories
Chemistry · 53d
Cleared Jun 19, 1989
CHOLESTEROL REAGENT SET
K893479 · CHH
American Monitor Corp.
Chemistry · 46d
Cleared Jun 16, 1989
VIS-DISK HCG (EIA) LYOPHILIZED JPL-044M
K891095 · DHA
Leeco Diagnostics, Inc.
Chemistry · 106d
Cleared Jun 16, 1989
VIS-DISK HCG (EIA) JPL-041M
K891096 · DHA
Leeco Diagnostics, Inc.
Chemistry · 106d
Cleared Jun 16, 1989
MICROTRAK EIA AUTOREADER
K891270 · JJQ
Syva Co.
Chemistry · 99d
Cleared Jun 16, 1989
AMRESCO CHOLESTEROL REAGENTS, PROD. # 7325
K891922 · CHH
American Research Products Co.
Chemistry · 81d
Cleared Jun 16, 1989
D-CHEM(TM) T-UPTAKE TEST KIT FOR T-UPTAKE DETERMIN
K892224 · KHQ
Photec Diagnostics, Inc.
Chemistry · 74d
Cleared Jun 16, 1989
IRON SYSTEM PACK REAGENTS
K892838 · JIY
Boehringer Mannheim Corp.
Chemistry · 59d
Cleared Jun 16, 1989
GLUCOMETER QA BLOOD GLUCOSE MTR/GLUCOFILM TEST ST
K893117 · CGA
Bayer Corp.
Chemistry · 52d
Cleared Jun 12, 1989
NEOCHROME(R) III GLUCOSE
K892002 · CGA
American Monitor Corp.
Chemistry · 76d
Cleared Jun 09, 1989
ASSAYED CHOLINESTERASE CONTROL
K885282 · JJX
Actio, Inc.
Chemistry · 171d
Cleared Jun 09, 1989
DIALBUMIN
K891544 · JIR
Exocell, Inc.
Chemistry · 84d
Cleared Jun 09, 1989
LITHIUM CONCENTRATE #SR1031, NA/K STANDARDS SR1030
K891574 · JGT
Em Diagnostic Systems, Inc.
Chemistry · 81d
Cleared Jun 09, 1989
BICARBONATE
K891991 · KHS
Boehringer Mannheim Corp.
Chemistry · 73d
Cleared Jun 09, 1989
REP SPE HI-RES SYSTEM NO. 3176, 3177, 3178
K892424 · CFF
Helena Laboratories
Chemistry · 60d