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
6985–7008 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared May 02, 1990
OLYMPUS INORGANIC PHOSPHORUS (2-REAGENT MODIFICA.)
K901807 · CEO
Em Diagnostic Systems, Inc.
Chemistry · 12d
Cleared May 01, 1990
DILECTRON URINARY CONDUCTIVITY PROBE
K891681 · JRE
Gyrus Medical , Ltd.
Chemistry · 405d
Cleared May 01, 1990
LIG/TDM A, B, C
K901212 · JJY
Ciba Corning Diagnostics Corp.
Chemistry · 48d
Cleared May 01, 1990
LUMATAG(TM) HCG CHEMILUMINESCENCE IMMUNOMETRIC
K901484 · JHI
London Diagnostics, Inc.
Chemistry · 33d
Cleared Apr 26, 1990
TECHNICON TESTPOINT(TM) LIGAND CONTROL
K900717 · JJY
Technicon Instruments Corp.
Chemistry · 71d
Cleared Apr 26, 1990
E/LUMINA(TM)/ALLEGRO LITE(TM) LUMINESCENCE MEASURE
K901542 · JJQ
Source Scientific Systems, Inc.
Chemistry · 24d
Cleared Apr 25, 1990
BLOOD GAS CALIBRATION STANDARD
K900819 · LCH
Cryogenic Rare Gas Laboratories, Inc.
Chemistry · 63d
Cleared Apr 25, 1990
COULTER TOTAL BILIRUBIN REAGENT
K901266 · CIG
Coulter Corp.
Chemistry · 40d
Cleared Apr 25, 1990
CREATININE REAGENT FOR AU5000 CLIN LAB ANAL-MODIFY
K901298 · CGX
Olympus Corp.
Chemistry · 36d
Cleared Apr 25, 1990
TECHNICON CHEM 1 CLINICAL ANALYZER FOR URINE URIC
K901693 · KNK
Technicon Instruments Corp.
Chemistry · 14d
Cleared Apr 25, 1990
NAD REDUCTION, ALT/SPGT CODES 7722,7723,7422,7522
K901702 · CKA
American Research Products Co.
Chemistry · 13d
Cleared Apr 19, 1990
AMRESCO CREATININE REAGENTS PRODUCT #7790, 7791
K900666 · CGX
American Research Products Co.
Chemistry · 65d
Cleared Apr 19, 1990
AMRESCO LDH-L REAGENTS PRODUCTS #7710, 7711
K900667 · CFJ
American Research Products Co.
Chemistry · 65d
Cleared Apr 19, 1990
MULTICONSTITUENT SERUM RANGE LINEARITY #88234
K901115 · JJY
Hichem Diagnostics
Chemistry · 41d
Cleared Apr 19, 1990
CHEM 1 CLINICAL ANALYZER (METHOD URINE CALCIUM)
K901226 · CIC
Technicon Instruments Corp.
Chemistry · 36d
Cleared Apr 19, 1990
COAT-A-COUNT PROLACTIN IRMA #:IKPR1, IKPR2
K901578 · CFT
Diagnostic Products Corp.
Chemistry · 15d
Cleared Apr 18, 1990
IMX HCG (LIST #03A63)
K900327 · JHI
Abbott Laboratories
Chemistry · 85d
Cleared Apr 16, 1990
KEMBLE LIQUID HANDLING SYSTEM DISPENSER
K896684 · JQW
Schiff & Co.
Chemistry · 139d
Cleared Apr 16, 1990
AMRESCO PRODUCT NUMBER 7728 (BILIRUBIN DPD)
K900571 · CIG
American Research Products Co.
Chemistry · 68d
Cleared Apr 16, 1990
CHEM-CHEX
K900993 · JJY
Streck Laboratories, Inc.
Chemistry · 45d
Cleared Apr 16, 1990
BOEHRINGER MANNHEIM/HITACHI 747 CHEMISTRY ANALYZER
K901003 · JJE
Boehringer Mannheim Corp.
Chemistry · 42d
Cleared Apr 16, 1990
EMDS(TM) CEREBROSPINAL FLUID PROTEIN, #67668/95
K901083 · JGQ
Em Diagnostic Systems, Inc.
Chemistry · 40d
Cleared Apr 16, 1990
COULTER GAMMA-GT (GGT) REAGENT
K901264 · JQB
Coulter Corp.
Chemistry · 31d
Cleared Apr 16, 1990
ES 300 IMMUNOASSAY SYSTEM
K901346 · JJE
Boehringer Mannheim Corp.
Chemistry · 24d