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
2017–2040 of 3,029
Search insights Median review: 57d Cleared: 100% Top manufacturer: Syva Co. Lead specialty: Toxicology
Cleared May 27, 1988
MODIFIED LABELING FOR TOXI-LAB BROAD SPECTRUM
K875181
Marion Laboratories, Inc.
Toxicology · 162d
Cleared May 27, 1988
LIQUID CHROMATO. COLUMNS
K880724 · DPM
Supelco, Inc.
Toxicology · 95d
Cleared May 27, 1988
GDS ENZYMATIC ACETAMINOPHEN REAGENT
K880829 · LDP
Gds Technology, LLC
Toxicology · 87d
Cleared May 27, 1988
IMMPULSE T, ASSAY REAGENTS
K881214 · CDP
Sclavo, Inc.
Toxicology · 67d
Cleared May 27, 1988
EZ-BEAD THEOPHYLLINE ENZYME IMMUNOASSAY KIT
K881257 · KLS
Immunotech Corp.
Toxicology · 65d
Cleared May 27, 1988
PARAMAX ALCOHOL AND AMMONIA CALIBRATOR, I & II
K881258 · JIX
Baxter Healthcare Corp
Toxicology · 65d
Cleared May 27, 1988
EMDS LIDOCAINE CALIBRATOR ITEM NO. 67XXX/95
K881337 · DLJ
Em Diagnostic Systems, Inc.
Toxicology · 59d
Cleared May 24, 1988
WESCOR SWEAT.CHEK SWEAT CONDUCTIVITY ANALYZER
K863395 · CGZ
Wescor, Inc.
Toxicology · 629d
Cleared Apr 21, 1988
TDX (R) AMPHETAMINE CLASS
K874770 · DKZ
Abbott Laboratories
Toxicology · 154d
Cleared Apr 19, 1988
EMIT VANCOMYCIN ASSAY
K881040 · LEH
Syva Co.
Toxicology · 39d
Cleared Apr 05, 1988
EMIT 700 CANNABINOID 100 NG CALIBRATOR & CONTROL
K875135 · DLJ
Syva Co.
Toxicology · 113d
Cleared Apr 05, 1988
LYPHOCHEK URINE TOXICOLOGY CONTROL - LOW
K880445 · DIF
Bio-Rad
Toxicology · 63d
Cleared Apr 05, 1988
DRUG MIXTURE CONTROL IN URINE
K880512 · DIF
Eastern Laboratories, Ltd.
Toxicology · 56d
Cleared Mar 11, 1988
REVISED LABELING FOR ADX COCAINE METABOLITE
K880009 · DIO
Abbott Laboratories
Toxicology · 67d
Cleared Mar 01, 1988
REVISED LABELING FOR ADX BARBITURATES
K880012 · DIS
Abbott Laboratories
Toxicology · 57d
Cleared Mar 01, 1988
REVISED LABELING FOR ADX AMPHETAMINE/METHAMPHETA.
K880013 · DKZ
Abbott Laboratories
Toxicology · 57d
Cleared Mar 01, 1988
REVISED LABELING FOR ADX CANNABINOIDS
K880015 · LDJ
Abbott Laboratories
Toxicology · 57d
Cleared Feb 25, 1988
LYPHOCHEK URINE TOXICOLOGY CONTROL - NEGATIVE
K880444 · DIF
Bio-Rad
Toxicology · 23d
Cleared Feb 19, 1988
IMMPULSE DIGOXIN ASSAY REAGENTS
K874748 · LCS
Sclavo, Inc.
Toxicology · 93d
Cleared Feb 18, 1988
COAT-A-COUNT OPIATES SCREEN TKOS1, TKOS5
K874808 · DJG
Diagnostic Products Corp.
Toxicology · 87d
Cleared Feb 16, 1988
ABUSCREEN(R) EIA AMPHETAMINE
K874836 · DKZ
Roche Diagnostic Systems, Inc.
Toxicology · 84d
Cleared Feb 11, 1988
IMMPULSE T4 ASSAY REAGENTS
K875081 · CDX
Sclavo, Inc.
Toxicology · 64d
Cleared Feb 11, 1988
REVISED LABELING FOR ADX OPIATES
K880010 · DJG
Abbott Laboratories
Toxicology · 38d
Cleared Feb 11, 1988
REVISED LABELING FOR ADX PHENCYCLIDINE
K880011 · LCL
Abbott Laboratories
Toxicology · 38d