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
7441–7464 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared May 03, 1989
TOTAL CHOLESTEROL REAGENT
K890334 · CHH
Alpkem Corp.
Chemistry · 100d
Cleared May 03, 1989
POTASSIUM AND SODIUM ELECTROLYTE ANALYZER
K890792 · CEM
Ionetics, Inc.
Chemistry · 75d
Cleared May 03, 1989
IQ CALCIUM
K891217 · CIC
Bd Becton Dickinson Vacutainer...
Chemistry · 57d
Cleared Apr 26, 1989
MRI NEO-TRYP TRYPSIN RIA
K883011 · JNO
Microbiological Research Corp.
Chemistry · 281d
Cleared Apr 26, 1989
QUIKREAD CHEM. ANALYZER & CHOLES. FOR WHOLE BLOOD
K890027 · CHH
Photec Diagnostics, Inc.
Chemistry · 112d
Cleared Apr 26, 1989
QUIKREAD CHEM. ANALYZER & CHOLES. FOR SERUM/PLASMA
K890267 · CHH
Photec Diagnostics, Inc.
Chemistry · 112d
Cleared Apr 26, 1989
RIA-GNOST INSULIN
K890837 · CFP
Cambridge Medical Technology
Chemistry · 64d
Cleared Apr 26, 1989
DSL 7900 ACTIVE DHEA-S (DSL #7900)
K891478 · JKC
Diagnostic Systems Laboratories, Inc.
Chemistry · 41d
Cleared Apr 26, 1989
ADVANCED PURIFICATION GLASS COLUMN
K891673 · DPM
Waters Chemical Products
Chemistry · 36d
Cleared Apr 21, 1989
LIQUICHEK(R) SERUM ALCOHOL CONTROL
K892004 · LAS
Bio-Rad
Chemistry · 24d
Cleared Apr 18, 1989
DIRECTIGEN1-2-3 BHCG PREGNANCY TEST
K890615 · JHI
Quidel Corp.
Chemistry · 70d
Cleared Apr 18, 1989
HI CHEM INORGANIC PHOSPHORUS REAGENT KIT #88196
K890773 · CEO
Hichem Diagnostics
Chemistry · 62d
Cleared Apr 18, 1989
IRON REAGENT
K891155 · CFM
Medical Analysis Systems, Inc.
Chemistry · 43d
Cleared Apr 18, 1989
VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM (VIDAS)
K891385 · DEW
Vitek Systems, Inc.
Chemistry · 40d
Cleared Apr 14, 1989
EMIT CONVENIENCE PACK: THYROXINE ASSAY
K890831 · KLI
Syva Co.
Chemistry · 52d
Cleared Apr 12, 1989
URIC ACID KIT, CODES 4825400 AND 4825050
K890319 · KNK
American Research Products Co.
Chemistry · 79d
Cleared Apr 10, 1989
HI CHEM CALCIUM REAGENT #88808
K890584 · CJY
Hichem Diagnostics
Chemistry · 63d
Cleared Apr 10, 1989
ABBOTT ALT-ACTIVATED (LIQUID, LIST #01A55)
K890698 · CKA
Abbott Laboratories
Chemistry · 59d
Cleared Apr 10, 1989
EXTEND INTENDED USE FOR ENZYME RINSE CONCENTRATE
K890990 · CHH
Hichem Diagnostics
Chemistry · 42d
Cleared Apr 10, 1989
VENTREX COATED TUBE T3 UPTAKE
K891068 · KHQ
Ventrex Laboratories, Inc.
Chemistry · 40d
Cleared Apr 10, 1989
HDL CHOLESTEROL REAGENT
K891117 · LBR
Pointe Scientific, Inc.,
Chemistry · 39d
Cleared Apr 10, 1989
BIOTROL CHEMISTRY URINE CONTROL
K891286 · JJW
Biotrol, USA, Inc.
Chemistry · 32d
Cleared Apr 04, 1989
GLUCOFILM TEST STRIPS & CONTROLS/GLUCOMETER 3
K890873 · CGA
Heraeus Kulzer, Inc.
Chemistry · 42d
Cleared Apr 04, 1989
TOTAL BILIRUBIN FOR CONTINUOUS FLOW
K891025 · CIG
Catachem, Inc.
Chemistry · 35d