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
5425–5448 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Oct 27, 1994
CARDIOCHEX
K944243 · JJT
Cala Diagnostics
Chemistry · 57d
Cleared Oct 25, 1994
PRO-STEP LH OVULATION PREDICTION TEST
K943252 · CEP
Disease Detection International, Inc.
Chemistry · 111d
Cleared Oct 25, 1994
BIOSIGN, ACCUSIGN, LIFESIGN, HCG SERUM/URINE
K944426 · JHI
Princeton BioMeditech Corp.
Chemistry · 43d
Cleared Oct 25, 1994
4 CHANNEL DISPENSER
K944556 · JQW
Tecan U.S., Inc.
Chemistry · 39d
Cleared Oct 21, 1994
CEDIA DAU AMPHETAMINES ASSAY
K943993 · DKZ
Microgenics Corp.
Chemistry · 66d
Cleared Oct 20, 1994
HCG PREGNANCY ONE STEP TEST STRIP FOR OTC USE
K941765 · LCX
Tcpi, Inc.
Chemistry · 209d
Cleared Oct 20, 1994
KODAK EXTACHEM CLINICAL CHEMISTRY SLIDE DIGOXIN (DGXN)
K942610 · LFM
Eastman Kodak Company
Chemistry · 140d
Cleared Oct 20, 1994
CEDIA T4 MAB ASSAY
K943019 · KLI
Microgenics Corp.
Chemistry · 118d
Cleared Oct 20, 1994
SEALITE SCIENCE, INC. AQUALITE(R) LH
K943188 · CEP
Sealite Sciences, Inc.
Chemistry · 107d
Cleared Oct 20, 1994
DMA GLUCOSE (OXIDASE) PROCEDURE
K943241 · CGA
Data Medical Associates, Inc.
Chemistry · 106d
Cleared Oct 20, 1994
MRX MICROPLATE READER
K943701 · JJQ
Dynatech Laboratories, Inc.
Chemistry · 83d
Cleared Oct 20, 1994
AVL OPTI PH/BLOOD GAS ANALYZER
K944089 · CHL
Avl Scientific Corp.
Chemistry · 59d
Cleared Oct 19, 1994
SERIES 600 CENTRIFUGE-FOUR SEPARATE VARIATIONS OF THE SAME BASE CENTRIFUGE
K944738 · JQC
Ducker CL
Chemistry · 23d
Cleared Oct 13, 1994
QUANTASE PHENYLALANINE ASSAY
K922547 · JNB
Porton Cambridge , Ltd.
Chemistry · 864d
Cleared Oct 07, 1994
URINARY CATECHOLAMINE KIT
K943099 · CHQ
Bioanalytical Systems, Inc.
Chemistry · 100d
Cleared Oct 06, 1994
ACE CEDIA PHENOBARBITAL ASSAY
K942501 · DLZ
Schiapparelli Biosystems, Inc.
Chemistry · 135d
Cleared Oct 04, 1994
MULTI ANALYTE LINEARITY SET
K936245 · JJY
Teco Diagnostics
Chemistry · 278d
Cleared Oct 04, 1994
ROCHE AMMONIA (VARIOUS)
K942048 · DKB
Roche Diagnostic Systems, Inc.
Chemistry · 159d
Cleared Oct 04, 1994
HITACHI 914 ANALYZER
K942364 · JJE
Boehringer Mannheim Corp.
Chemistry · 140d
Cleared Oct 04, 1994
KOVA LIQUA-TROL
K942853 · JJW
Hycor Biomedical, Inc.
Chemistry · 110d
Cleared Oct 04, 1994
HICHEM ENZYME VERIFIER KIT
K943684 · JJT
Hi Chem, Inc.
Chemistry · 67d
Cleared Oct 04, 1994
SWEAT CONTROLS FOR CYSTIC FIBROSIS TESTING
K943925 · JJR
Quantimetrix Corp.
Chemistry · 53d
Cleared Oct 03, 1994
ELEGANCE NEONATAL TSH ELISA
K935049 · JLW
Bioclone Australia Pty , Ltd.
Chemistry · 348d
Cleared Oct 03, 1994
DUPONT ACA PLUS THYROID STIMULATING HORMONE SYSTEM
K941146 · JLW
Dupont Medical Products
Chemistry · 207d