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
5929–5952 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Feb 17, 1993
VISTA(R) HUMAN CHORIONIC GONADOTROPIN (HCG) ASSAY
K926342 · JHI
Syva Co.
Chemistry · 62d
Cleared Feb 12, 1993
MINIVIDAS INSTRUMENT
K923579 · JJE
Biomerieux Vitek, Inc.
Chemistry · 207d
Cleared Feb 12, 1993
VIDAS ESTRADIOL (E2) ASSAY
K925498 · CHP
Biomerieux Vitek, Inc.
Chemistry · 105d
Cleared Feb 12, 1993
HI CHEM CO2 ACID REAGENT KIT,PRODUCT NUMBER 88812
K925552 · JFL
Hichem Diagnostics
Chemistry · 101d
Cleared Feb 12, 1993
HI CHEM CO2 ALKALINE BUFFER REAGENT KIT,PROD#88813
K925553 · JFL
Hichem Diagnostics
Chemistry · 101d
Cleared Feb 12, 1993
SYNCHRON CX5CE CLINICAL ANALYZER
K926060 · JJE
Beckman Instruments, Inc.
Chemistry · 73d
Cleared Feb 08, 1993
VACUPLUS(R) STAR-SEP(TM)
K924363 · JKA
Starplex Scientific, Inc.
Chemistry · 164d
Cleared Feb 08, 1993
OLYMPUS ALBUMIN REAGENT
K924368 · CIX
Olympus Corp.
Chemistry · 164d
Cleared Feb 08, 1993
OLYMPUS CHOLESTEROL REAGENT
K925603 · CHH
Olympus Corp.
Chemistry · 95d
Cleared Feb 08, 1993
ACCESS TOTAL BHCG ASSAY
K926198 · JHI
Bio-Rad Laboratories, Inc.
Chemistry · 61d
Cleared Feb 05, 1993
LACTATE DEHYDROGENASE (LD) TEST ITEM #65418
K924703 · CFJ
Em Diagnostic Systems, Inc.
Chemistry · 141d
Cleared Feb 05, 1993
ABBOTT QUICKSTART LD-1, MODIFICATION
K925188 · JGF
Em Diagnostic Systems, Inc.
Chemistry · 120d
Cleared Feb 05, 1993
OLYLMPUS ALANINE AMINOTRANSFERASE REAGENT
K925339 · CKA
Olympus Corp.
Chemistry · 108d
Cleared Feb 05, 1993
KODAK AMERLITE CK-MB CONTROL SERA LAN.4413
K925880 · JJX
Eastman Kodak Company
Chemistry · 78d
Cleared Feb 03, 1993
REFLAB SYSTEM PACK LIQUID CO2 REAGENT
K926320 · CHS
Medical Analysis Systems, Inc.
Chemistry · 50d
Cleared Feb 02, 1993
IMMUCHEM LH-MW ELISA
K922944 · CEP
Icn Biomedicals, Inc.
Chemistry · 229d
Cleared Feb 02, 1993
SAS ONE STEP PREGNANCY
K926204 · JHI
Sa Scientific, Inc.
Chemistry · 55d
Cleared Jan 28, 1993
CHOLESTEROL TEST ITEM# 42374/93, 42322/R1
K924508 · CHH
Em Diagnostic Systems, Inc.
Chemistry · 146d
Cleared Jan 28, 1993
NOVA 8 CRT ANALYZER
K924547 · JGS
Nova Biomedical Corp.
Chemistry · 141d
Cleared Jan 28, 1993
SUGAR CHEX LINEARITY FOR THE ONE TOUCH
K925479 · JJX
Streck Laboratories, Inc.
Chemistry · 147d
Cleared Jan 28, 1993
CLINITEK 200+ URINE CHEMISTRY ANALYZER
K926359 · KQO
Heraeus Kulzer, Inc.
Chemistry · 38d
Cleared Jan 28, 1993
ISE CALIBRATOR FOR DUPONT DIMENSION
K926518 · JIX
Alko Diagnostic Corp.
Chemistry · 29d
Cleared Jan 27, 1993
ROCHE COBAS FUTURA GLUCOSE
K922811 · CFR
Roche Diagnostic Systems, Inc.
Chemistry · 231d
Cleared Jan 27, 1993
URINE MAGNESIUM METHOD FOR TECHNICON CHEM SYSTEMS
K926144 · JGJ
Heraeus Kulzer, Inc.
Chemistry · 51d