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

467 results for "Syva Co."
25–48 of 467
Search insights Median review: 33d Cleared: 100% Top manufacturer: Syva Co. Lead specialty: Toxicology
Cleared Feb 01, 2000
SYVA EMIT II PLUS PROPOXYPHENE ASSAY, MODELS 9G029UL/9G129UL
K993981 · JXN
Syva Co.
Toxicology · 69d
Cleared Feb 01, 2000
SYVA EMIT II PLUS ETHYL ALCOHOL ASSAY, MODELS 9K309UL/9K409UL
K993980 · DML
Syva Co.
Toxicology · 69d
Cleared Jan 27, 2000
SYVA EMIT II PLUS COCAINE METABOLITE ASSAY, MODEL 9H029UL
K993988 · DIO
Syva Co.
Toxicology · 64d
Cleared Jan 27, 2000
SYVA EMIT II PLUS BARBITURATE ASSAY, MODEL 9D029UL/9D129UL
K993987 · KLT
Syva Co.
Toxicology · 64d
Cleared Jan 27, 2000
SYVA EMIT II PLUS METHAQUALONE ASSAY, MODEL 9Q029UL/9Q129UL
K993986 · KXS
Syva Co.
Toxicology · 64d
Cleared Jan 27, 2000
SYVA EMIT II PLUS BENZODIAZEPINE ASSAY, MODELS 9F029UL/9F129UL
K993985 · JXM
Syva Co.
Toxicology · 64d
Cleared Jan 27, 2000
SYVA EMIT II PLUS PHENCYCLIDINE ASSAY, MODEL 9J029UL
K993983 · LCM
Syva Co.
Toxicology · 64d
Cleared Jan 27, 2000
SYVA EMIT II PLUS AMPHETAMINE/METHAMPHETAMINE ASSAY 9C029UL/9C129UL
K993982 · LAF
Syva Co.
Toxicology · 64d
Cleared Jan 27, 2000
ABBOTT AEROSET PHENOBARBITAL ASSEY AND CALIBRATORS
K993031 · DLZ
Syva Co.
Toxicology · 140d
Cleared Jan 27, 2000
ABBOTT AEROSET THEOPHYLLINE ASSAY AND CALIBRATORS
K993029 · KLS
Syva Co.
Toxicology · 140d
Cleared Jan 27, 2000
ABBOTT AEROSET CARBAMAZEPINE ASSAY AND CALIBRATORS
K993028 · KLT
Syva Co.
Toxicology · 140d
Cleared Jan 27, 2000
ABBOT AEROSET PHENYTOIN ASSAY & ABBOT AEROSET PHENYTOIN CALIBRATORS
K993026 · DIP
Syva Co.
Toxicology · 140d
Cleared Jan 20, 2000
SYVA EMIT II PLUS METHADONE ASSAY, MODELS 9E029UL/9E129UL
K994005 · DJR
Syva Co.
Chemistry · 57d
Cleared Jan 18, 2000
SYVA EMIT II PLUS CANNABINOID ASSAY, MODELS 9N029UL/9N129UL
K993984 · LDJ
Syva Co.
Toxicology · 55d
Cleared Dec 21, 1999
EMIT CALIBRATER/CONTROL LEVEL 0, LEVEL 1, LEVEL 2, LEVEL 3, LEVEL 4, LEVEL 5
K993755 · DKB
Syva Co.
Toxicology · 46d
Cleared Jan 22, 1999
MODIFICATION OF EMIT D.A.U. OPIATES ASSAY
K984232 · DJG
Syva Co.
Toxicology · 58d
Cleared Jun 01, 1995
EMIT 2000 DIGOXIN ASSAY
K951755 · KXT
Syva Co.
Chemistry · 45d
Cleared Mar 24, 1995
EMIT IIC CALIBRATORS
K935192 · DKB
Syva Co.
Chemistry · 514d
Cleared Feb 22, 1995
EMIT IIC CANNABINOID ASSAY
K940158 · LDJ
Syva Co.
Toxicology · 406d
Cleared Feb 22, 1995
EMIT(R) IIC AMPHETAMINE ASSAY
K935352 · DKZ
Syva Co.
Toxicology · 474d
Cleared Feb 22, 1995
EMIT IIC COCAINE METABOLITE ASSAY
K935323 · DIO
Syva Co.
Toxicology · 475d
Cleared Feb 22, 1995
EMIT IIC PHENCYCLIDINE ASSAY
K935191 · LCM
Syva Co.
Toxicology · 484d
Cleared Feb 22, 1995
EMIT IIC BARBITURATE ASSAY
K935116 · DIS
Syva Co.
Toxicology · 483d
Cleared Nov 15, 1994
EMIT 2000 DIGOXIN ASSAY
K943500 · KXT
Syva Co.
Toxicology · 133d