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
5473–5496 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Aug 26, 1994
ROCHE REAGENT FOR CREATININE
K941837 · CGX
Roche Diagnostic Systems, Inc.
Chemistry · 135d
Cleared Aug 26, 1994
CLP TOTAL IRON AND UIBC/TIBC LINEARITY CONTROL SET
K942284 · JJX
Creative Laboratory Products, Inc.
Chemistry · 107d
Cleared Aug 26, 1994
STAR I WORKSTATION
K942290 · JQW
Standard Engineering
Chemistry · 107d
Cleared Aug 26, 1994
AURAFLEX SYSTEMS
K942443 · JJE
Organon Teknika Corp.
Chemistry · 95d
Cleared Aug 24, 1994
CK-MB ASSAY, CATALOGUE NUMBER 317-10
K942773 · CGS
Diagnostic Chemicals , Ltd.
Chemistry · 72d
Cleared Aug 24, 1994
AVL COMPACT 1 PH/BLOOD GAS ANALYZER
K943570 · CHL
Avl Scientific Corp.
Chemistry · 33d
Cleared Aug 18, 1994
TRAK LIQUID CEREBROSPINAL FLUID CONTROL LEVELS 1 & 2
K941328 · JJY
Medical Analysis Systems, Inc.
Chemistry · 153d
Cleared Aug 18, 1994
SEALITE SCIENCES INC.
K941983 · DHA
Sealite Sciences, Inc.
Chemistry · 115d
Cleared Aug 18, 1994
DUPONT APC BLOOD COLLECTION CONTAINER WITH THROMBOPLASTIN
K942241 · JKA
Dupont Medical Products
Chemistry · 101d
Cleared Aug 17, 1994
CARDIO REP LD
K940224 · CFE
Helena Laboratories
Chemistry · 211d
Cleared Aug 17, 1994
DUPONT APC BLOOD COLLECTION CONTAINER WITH LITHIUM HEPARIN
K942240 · JKA
Dupont Medical Products
Chemistry · 100d
Cleared Aug 16, 1994
IMX ULTRASENSISTIVE HTSH II
K942566 · JLW
Abbott Laboratories
Chemistry · 77d
Cleared Aug 15, 1994
VISTA B12 ASSAY
K941235 · CDD
Syva Co.
Chemistry · 153d
Cleared Aug 09, 1994
DUPONT ACA PLUS FSH/LH/PROLACTIN CALIBRATOR
K941219 · JIX
Dupont Medical Products
Chemistry · 148d
Cleared Aug 02, 1994
AMMONIA ASSAY CAT. NO. 200-02
K932556 · JIF
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 433d
Cleared Aug 02, 1994
INCSTAR ACTH IRMA
K940271 · CKG
Incstar Corp.
Chemistry · 193d
Cleared Aug 02, 1994
MICROTAINER BRAND TUBE WITH EDTA(K2)
K940905 · JKA
Bd Becton Dickinson Vacutainer...
Chemistry · 159d
Cleared Aug 02, 1994
HI CHEM AQUEOUS GLUCOSE CONTROL, LOW, MED, HIGH
K941433 · JJX
Hichem Diagnostics
Chemistry · 131d
Cleared Aug 02, 1994
KINASE ISOENZYME
K943024 · JHS
Dupont Medical Products
Chemistry · 68d
Cleared Aug 01, 1994
MODEL 644 SWEAT DILUENT
K935228 · CGZ
Ciba Corning Diagnostics Corp.
Chemistry · 273d
Cleared Aug 01, 1994
LIQUID AMYLASE (CNPG3) REAGENT SET
K940735 · CIJ
Pointe Scientific, Inc.,
Chemistry · 165d
Cleared Jul 28, 1994
OPUS FT4 TEST SYSTEM
K940507 · CEC
Pb Diagnostic Systems, Inc.
Chemistry · 176d
Cleared Jul 28, 1994
SERUM VOLATILES CONTROL - LEVELS 1 AND 2
K941698 · JJY
More Diagnostics
Chemistry · 113d
Cleared Jul 28, 1994
WHOLE BLOOD VOLATILES CONTROL, LEVELS 1 AND 2
K941876 · JJY
More Diagnostics
Chemistry · 101d