Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Toxicology ×
3,029 results
1441–1464 of 3,029
Search insights Median review: 57d Cleared: 100% Top manufacturer: Syva Co. Lead specialty: Toxicology
Cleared Jun 21, 1994
AXSYM THEOPHYLLINE
K935373 · KLS
Abbott Laboratories
Toxicology · 225d
Cleared Jun 21, 1994
AXSYM CARBAMAZEPHINE
K935374 · KLT
Abbott Laboratories
Toxicology · 225d
Cleared Jun 21, 1994
AXSYM PHENYTOIN ASSAY
K935375 · LGR
Abbott Laboratories
Toxicology · 225d
Cleared Jun 21, 1994
AXSYM GENTAMICIN
K935376 · LCD
Abbott Mfg., Inc.
Toxicology · 225d
Cleared Jun 21, 1994
AXSYM VANCOMYCIN
K940595 · LEH
Abbott Laboratories
Toxicology · 131d
Cleared Jun 21, 1994
AXSYM PHENOBARBITAL
K940596 · LGQ
Abbott Laboratories
Toxicology · 131d
Cleared Jun 13, 1994
CEDIA DIGOXIN PLUS ASSAY
K941255 · KXT
Microgenics Corp.
Toxicology · 91d
Cleared Jun 13, 1994
COBAS-FP REAGENTS AND CALIBRATORS
K941712 · LGJ
Roche Diagnostic Systems, Inc.
Toxicology · 68d
Cleared Jun 02, 1994
QMS CARBAMAZEPINE ASSAY
K940374 · KLT
Seradyn, Inc.
Toxicology · 127d
Cleared Jun 02, 1994
QMS GENTAMICIN ASSAY
K940376 · LCD
Seradyn, Inc.
Toxicology · 127d
Cleared Jun 02, 1994
USDT CANNABINOID (THC) ASSAY COLUMN CATALOG NO. 9000-500
K940912 · LDJ
U.S. Drug Testing, Inc.
Toxicology · 97d
Cleared Jun 02, 1994
CEDIA DAU COCAINE ASSAY
K941310 · DIO
Microgenics Corp.
Toxicology · 80d
Cleared May 27, 1994
CEDIA DAU BENZODIAZEPINE ASSAY
K940159 · JXM
Microgenics Corp.
Toxicology · 135d
Cleared May 17, 1994
CEDIA DAU MULTI-LEVEL THC ASSAY, HITACHI 911 REAGENT/ AND THE HITACHI 747...
K940649 · LDJ
Microgenics Corp.
Toxicology · 91d
Cleared May 03, 1994
METHAQUALONE ENZYME IMMUNOASSAY
K940123 · KXS
Diagnostic Reagents, Inc.
Toxicology · 113d
Cleared Apr 26, 1994
PARAMAX ALCOHOL REAGENT
K934275 · DIC
Baxter Diagnostics, Inc.
Toxicology · 238d
Cleared Apr 26, 1994
CEDIA DAU CONTROLS
K934650 · DIF
Medical Analysis Systems, Inc.
Toxicology · 209d
Cleared Apr 26, 1994
PERKIN-ELMER SERIES 200 LIQ CHROMATOGRAPHIC PUMP
K935666 · KIE
The Perkin-Elmer Corp.
Toxicology · 151d
Cleared Apr 26, 1994
ACCESS CORTISOL REAGENTS
K940221 · CGR
Bio-Rad Laboratories, Inc.
Toxicology · 98d
Cleared Apr 25, 1994
KODAK EKTACHEM DTSC II SLIDES (LI)
K934106 · JIH
Eastman Kodak Company
Toxicology · 245d
Cleared Apr 15, 1994
VIGIL PRX CHEMISTRY CONTROL
K936184 · JJY
Beckman-Diagnostic Systems Group
Toxicology · 109d
Cleared Apr 12, 1994
USDT PHENCYCLIDINE (PCP) ASSAY COLUMN CAT. NO. 9000-400
K935629 · LCM
U.S. Drug Testing, Inc.
Toxicology · 140d
Cleared Apr 06, 1994
URINE HEROIN/MORPHINE DIRECT RIA KIT (I-125)
K933572 · DOE
Immunalysis Corporation
Toxicology · 257d
Cleared Apr 06, 1994
EMIT 2000 DIGOXIN ASSAY/CALIBRATORS MODIFICATION
K934135 · KXT
Syva Co.
Toxicology · 224d