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
5545–5568 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared May 23, 1994
CIBA CORNING ACS:180 AUTO CHEMILUMIN SYST, MODIF
K940810 · JJE
Ciba Corning Diagnostics Corp.
Chemistry · 90d
Cleared May 19, 1994
ANI BIOCARD(TM) HCG TEST
K933794 · LCX
Canadian Bioclinical, Ltd.
Chemistry · 288d
Cleared May 19, 1994
DIRECTDRAW SUPERSERUM-G DIRECTDRAW SUPERSERUM-MINI-G
K941159 · JKA
International Technidyne Corp.
Chemistry · 69d
Cleared May 17, 1994
LIPASE-PS ASSAY PROCEDURE NO. 805
K941085 · CHI
Sigma Diagnostics, Inc.
Chemistry · 70d
Cleared May 17, 1994
STANBIO ALKALINE PHOSPHATASE (LIQUICOLOR) TEST SET
K941313 · CJE
Stanbio Laboratory
Chemistry · 60d
Cleared May 13, 1994
CIDBA CORNING ACS CORTISOL IMMUNOASSAY
K934317 · JFT
Ciba Corning Diagnostics Corp.
Chemistry · 254d
Cleared May 13, 1994
HICHEM CALCIUM REAGENT FOR THE SYNCHRON CX3 PROD. NO. 88808
K941764 · CJY
Hi Chem, Inc.
Chemistry · 45d
Cleared May 10, 1994
DRUG, INSURANCE, URINALYSIS, BLOOD/URINE TEST KITS
K931474 · KDW
Gbf Medical Group
Chemistry · 412d
Cleared May 10, 1994
GLUCOFILM TEST STRIPS
K936212 · CGA
Heraeus Kulzer, Inc.
Chemistry · 133d
Cleared May 10, 1994
I-STAT 200 PORTABLE CLINICAL ANALYZER
K940918 · CHL
I-Stat Corp.
Chemistry · 74d
Cleared May 09, 1994
ACTIVE DEHYDROEPIANDROSTERONE (DHEA)(DSL 9000)
K935014 · JKC
Diagnostic Systems Laboratories, Inc.
Chemistry · 201d
Cleared May 09, 1994
URINARY ALBUMIN TEST PACK
K936202 · JIQ
Dupont Medical Products
Chemistry · 131d
Cleared May 03, 1994
ACE CLINICAL CHEMISTRY SYSTEM
K940267 · KXT
Schiapparelli Biosystems, Inc.
Chemistry · 102d
Cleared May 03, 1994
IMPACT
K940390 · JQW
Matrix Technologies Corp.
Chemistry · 97d
Cleared May 03, 1994
SYNERMED AMYLASE REAGENT KIT
K941091 · JFJ
Synermed, Inc.
Chemistry · 56d
Cleared May 03, 1994
LIQUID ALT(SGPT) REAGENT SET
K941287 · CKA
Pointe Scientific, Inc.,
Chemistry · 47d
Cleared May 02, 1994
MONOJECT BLOOD COLLECTION TUBES W/SAFETY STOPPER
K940058 · GIM
Sherwood Medical Co.
Chemistry · 117d
Cleared May 02, 1994
LIQUID AST (SGOT)REAGENT SET
K941132 · CIT
Pointe Scientific, Inc.,
Chemistry · 54d
Cleared Apr 26, 1994
CARDIAC T ELISA TROPONIN-T
K924392 · MMI
Boehringer Mannheim Corp.
Chemistry · 603d
Cleared Apr 26, 1994
RESOLVE SYSTEMS ALKALINE PHOSPHATASE TEST KIT
K934013 · CIN
Isolab, Inc.
Chemistry · 251d
Cleared Apr 26, 1994
BECKMAN DIRECT BILIRUBIN REAGENT
K934068 · CIG
Beckman-Diagnostic Systems Group
Chemistry · 249d
Cleared Apr 26, 1994
BECKMAN AMMONIA AMM REAGENT/ CX AMMONIA CALIBRATOR
K934925 · JIF
Beckman Instruments, Inc.
Chemistry · 193d
Cleared Apr 26, 1994
EML 100
K935120 · JGS
Radiometer America, Inc.
Chemistry · 181d
Cleared Apr 26, 1994
NANOSEP N10
K935496 · JJH
Intersep , Ltd.
Chemistry · 162d