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
7777–7800 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Aug 15, 1988
CANTROL HDL CHOLESTEROL PRECIPI. REAG. AND TUBES
K882488 · LBR
Canyon Diagnostics, Inc.
Chemistry · 60d
Cleared Aug 09, 1988
ABBOTT SPECTRUM SIMULSTAT GLUCOSE/BUN REAGENT
K882334 · CFR
Abbott Laboratories
Chemistry · 64d
Cleared Aug 09, 1988
MONOJECT(R) SNAP-OVER SAFETY CAP
K882614 · JKA
Sherwood Medical Co.
Chemistry · 46d
Cleared Aug 08, 1988
COTUBE HCG IRMA TEST
K882155 · JHI
Bio-Rad
Chemistry · 80d
Cleared Aug 08, 1988
MAGNESIUM REAGENT SET
K882256 · JGJ
Tech-Neal Scientific, Inc.
Chemistry · 69d
Cleared Aug 08, 1988
LH SEROZYME IMMUNOENZYMETRIC ASSAY KIT,MAG SOL PHA
K882340 · CEP
Serono Diagnostics, Inc.
Chemistry · 62d
Cleared Aug 08, 1988
REP HDL ELECTROPHORESIS METHOD
K882368 · LBT
Helena Laboratories
Chemistry · 61d
Cleared Aug 08, 1988
CLEANTECH SYSTEM
K882539 · JKA
Schiff & Co.
Chemistry · 48d
Cleared Aug 08, 1988
PROFILE ONE OMNI
K882559 · JJE
Modular Diagnostic Systems, Inc.
Chemistry · 48d
Cleared Aug 08, 1988
A-KEM CALCIUM REAGENT KIT FOR ASTRA SYSTEM
K882586 · CIC
A-Kem, Inc.
Chemistry · 46d
Cleared Aug 08, 1988
A-KEM ALBUMIN REAGENT KIT FOR ASTRA SYSTEM
K882587 · CIX
A-Kem, Inc.
Chemistry · 46d
Cleared Aug 08, 1988
PHARMACIA IGE RIA ULTRA
K882625 · DGC
Pharmacia, Inc.
Chemistry · 42d
Cleared Aug 08, 1988
AMERLITE TOTAL THYROID CONTROL SERA LAN.4001
K882727 · JJY
Amersham Corp.
Chemistry · 38d
Cleared Aug 08, 1988
IMX CKMB
K883013 · JHY
Abbott Laboratories
Chemistry · 20d
Cleared Aug 04, 1988
PHASE II LH KIT
K882252 · CEP
Vitek Systems, Inc.
Chemistry · 65d
Cleared Aug 03, 1988
VISION(R) TOTAL BILIRUBIN WITH A NEONATAL CLAIM
K880437 · CIG
Abbott Laboratories
Chemistry · 183d
Cleared Aug 02, 1988
QLT ABSOLUTE URINE-HCG PREGNANCY TEST
K881806 · JHI
Quadra Logic Technologies, Inc.
Chemistry · 96d
Cleared Aug 02, 1988
MODIFICATION OF BEHRING RAPIMAT II/T
K882095 · JJQ
Behring Diagnostics, Inc.
Chemistry · 75d
Cleared Aug 02, 1988
MEDIBLEND (TM) CLINICAL BLOOD GAS MIXTURES
K882209 · CHL
Linde Div. Union Carbide Corp.
Chemistry · 68d
Cleared Aug 02, 1988
CALIBRATION KIT
K882220 · JIW
King Diagnostics, Inc.
Chemistry · 68d
Cleared Aug 02, 1988
D-CHEM
K882307 · JJE
Photec Diagnostics, Inc.
Chemistry · 60d
Cleared Aug 02, 1988
DIAZO, COLORIMETRIC BILIRUBIN
K882459 · CIG
Tech-Neal Scientific, Inc.
Chemistry · 48d
Cleared Aug 02, 1988
ENZYMATIC CO2 REAGENT SET
K882497 · KHS
American Monitor Corp.
Chemistry · 46d
Cleared Jul 28, 1988
AMERLITE LH-30 ASSAY, LAN.0082/2082 240/144 TEST
K880933 · CEP
Amersham Corp.
Chemistry · 143d