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
6889–6912 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Jul 19, 1990
BIURET (COLORMETRIC), TOTAL PROTEIN
K901527 · CEK
American Research Products Co.
Chemistry · 108d
Cleared Jul 19, 1990
BLOOD GAS/ISE CONTROLS
K902094 · JJY
Phoenix Diagnostics, Inc.
Chemistry · 72d
Cleared Jul 19, 1990
EPC ELECTRONIC PIPETTING SYSTEM
K902592 · JQW
Ulster Scientific, Inc.
Chemistry · 37d
Cleared Jul 19, 1990
BILIRUBIN CONTROL
K902616 · JJY
Phoenix Diagnostics, Inc.
Chemistry · 36d
Cleared Jul 19, 1990
AFFINITY PROLACTIN TEST SYSTEM
K902698 · CFT
Bd Becton Dickinson Vacutainer...
Chemistry · 30d
Cleared Jul 17, 1990
TECHNICON RA-2000(TM) SYSTEM
K901410 · JJC
Technicon Instruments Corp.
Chemistry · 113d
Cleared Jul 17, 1990
MODIFIED OVUGEN
K902208 · CEP
Biogenex Laboratories
Chemistry · 62d
Cleared Jul 17, 1990
LVM QUALITY CONTROL SERUM
K902235 · JJY
Ciba Corning Diagnostics Corp.
Chemistry · 61d
Cleared Jul 17, 1990
CALCIUM:ARSENAZO III
K902476 · CJY
Amresco, Inc.
Chemistry · 42d
Cleared Jul 17, 1990
CALCIUM REAGENT CODE 7732, 7733, 7532 & 7432
K902479 · CIC
Amresco, Inc.
Chemistry · 42d
Cleared Jul 17, 1990
ROCHE COBAS READY ALKALINE PHOSPHATASE REAGENT
K902560 · CJE
Roche Diagnostic Systems, Inc.
Chemistry · 36d
Cleared Jul 17, 1990
HI CHEM TOTAL PROTEIN/ALBUMIN SERUM RANGE LIN STND
K902673 · JJY
Hi Chem, Inc.
Chemistry · 29d
Cleared Jul 17, 1990
BECKMAN TOTAL BILIRUBIN TRIGGERED (TB-T) KIT
K902801 · CIG
Beckman Instruments, Inc.
Chemistry · 20d
Cleared Jul 16, 1990
PTH-MM II 125I RADIOIMMUNOASSAY (RIA)
K901711 · CEW
Incstar Corp.
Chemistry · 94d
Cleared Jul 16, 1990
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (SALI)
K902356 · DKJ
Eastman Kodak Company
Chemistry · 48d
Cleared Jul 16, 1990
ACID PHOSPHATASE REAGENT SET
K902495 · CKB
Tech Intl. Co.
Chemistry · 41d
Cleared Jul 16, 1990
SHAPE-ACTIO URINALYSIS CONTROLS(ASSAYED & UNASSAY)
K902699 · JJW
Actio, Inc.
Chemistry · 27d
Cleared Jul 16, 1990
CHEM-CHEX BILIRUBIN
K902867 · JJX
Streck Laboratories, Inc.
Chemistry · 17d
Cleared Jul 10, 1990
PROTEIN TEST FOR URINE AND CSF
K900733 · CEK
Elite Technology, Inc.
Chemistry · 144d
Cleared Jul 10, 1990
CHLORIDE REAGENT FOR THE AU5000 CLINICAL LAB. ANA.
K901500 · CHJ
Olympus Corp.
Chemistry · 103d
Cleared Jul 10, 1990
MEDISENSE PEN 2/COMPANION 2 BLOOD GLUCOSE SYSTEM
K901613 · CGA
Medisense, Inc.
Chemistry · 95d
Cleared Jul 10, 1990
CREATINE KINASE-MB TEST (MB-DS) ITEM #67655
K902483 · CGS
Em Diagnostic Systems, Inc.
Chemistry · 35d
Cleared Jul 10, 1990
PRECINORM(R) IM NORMAL IMMUNOASSAY CONTROL SERUM
K902536 · JJY
Boehringer Mannheim Corp.
Chemistry · 33d
Cleared Jul 10, 1990
SODIUM REAGENT SET
K902572 · CEI
Tech Intl. Co.
Chemistry · 29d