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."
1–24 of 467
Search insights Median review: 33d Cleared: 100% Top manufacturer: Syva Co. Lead specialty: Toxicology
Cleared Aug 13, 2001
EMIT (R) TOX SALICYLIC ASSAY, MODEL 7SO19UL, EMIT (R) TOX SALICYLIC ACID...
K011878 · DKJ
Syva Co.
Toxicology · 59d
Cleared Aug 03, 2001
EMIT II PLUS MONOCLONAL AMPHETAMINE/METHAMPHETAMINE ASSAY MODEL OSR9C229
K012257 · DKZ
Syva Co.
Chemistry · 16d
Cleared Jul 02, 2001
EMIT 2000 VALPROIC ACID ASSAY, MODEL OSR4G229UL
K011947 · LEG
Syva Co.
Toxicology · 11d
Cleared Jul 02, 2001
EMIT 2000 DIGOXIN ASSAY, MODEL OSR4H229
K011920 · KXT
Syva Co., Dade Behring, Inc.
Toxicology · 12d
Cleared Jun 18, 2001
EMIT 2000 N-ACETYLPROCAINAMIDE ASSAY, MODEL OSR4N229
K011620 · LAN
Syva Co., Dade Behring, Inc.
Toxicology · 24d
Cleared Jun 12, 2001
EMIT 2000 QUINIDINE ASSAY, MODEL OSR4Q229
K011605 · LBZ
Syva Co., Dade Behring, Inc.
Toxicology · 19d
Cleared Jun 06, 2001
EMIT 2000 PHENOBARBITAL ASSAY, MODEL OSR4D229
K011528 · DLZ
Syva Co.
Chemistry · 20d
Cleared May 17, 2001
EMIT 2000 PHENYTOIN ASSAY, MODEL 0SR4A229
K011347 · DIP
Syva Co.
Toxicology · 15d
Cleared May 17, 2001
EMIT II PLUS CANNABINOID ASSAY, MODEL OSR9N229
K011300 · LDJ
Syva Co., Dade Behring, Inc.
Toxicology · 17d
Cleared May 16, 2001
EMIT II PLUS BENZODIAZEPINE ASSAY, MODEL 0SR9F229
K011306 · JXM
Syva Co., Dade Behring, Inc.
Toxicology · 16d
Cleared May 15, 2001
EMIT II PLUS OPIATE ASSAY, MODEL OSR9B229
K011289 · DJG
Syva Co., Dade Behring, Inc.
Toxicology · 18d
Cleared May 15, 2001
MODIFICATION TO THE EMIT II PLUS PHENCYCLIDINE ASSAY, MODEL OSR9J229
K011161 · LCM
Syva Co., Dade Behring, Inc.
Toxicology · 29d
Cleared May 10, 2001
MODIFICATION TO EMIT 2000 THEOPHYLLINE ASSAY, MODEL OSR 4P229
K011166 · KLS
Syva Co., Dade Behring, Inc.
Chemistry · 24d
Cleared May 10, 2001
MODIFICATION TO THE EMIT II PLUS METHAQUALONE ASSAY, MODEL OSR9Q229
K011164 · KXS
Syva Co., Dade Behring, Inc.
Toxicology · 24d
Cleared May 10, 2001
MODIFICATION TO THE EMIT II PLUS PROPOXYPHENE ASSAY, MODEL OSR9G229
K011163 · JXN
Syva Co., Dade Behring, Inc.
Chemistry · 24d
Cleared May 02, 2001
MODIFICATION TO THE EMIT II PLUS COCAINE METABOLITE ASSAY
K011162 · DIO
Syva Co., Dade Behring, Inc.
Toxicology · 16d
Cleared Apr 26, 2001
EMIT II PLUS METHADONE ASSAY, MODEL OSRE229
K010962 · DJR
Syva Co., Dade Behring, Inc.
Toxicology · 27d
Cleared Apr 26, 2001
EMIT II PLUS ETHYL ALCOHOL ASSAY, MODEL OSR9K229
K010960 · DIC
Syva Co., Dade Behring, Inc.
Toxicology · 27d
Cleared Apr 20, 2001
EMIT 2000 GENTAMICIN PLUS ASSAY
K010984 · LCD
Syva Co., Dade Behring, Inc.
Toxicology · 18d
Cleared Apr 20, 2001
EMIT II PLUS BARBITUATE ASSAY, MODEL 0SR9D0229
K010934 · DIS
Syva Co., Dade Behring, Inc.
Toxicology · 23d
Cleared Apr 13, 2001
EMIT 2000 CARBAMAZEPINE ASSAY, MODEL OSR4F229
K010814 · KLT
Syva Co., Dade Behring, Inc.
Toxicology · 25d
Cleared Apr 13, 2001
EMIT 2000 PROCAINAMIDE ASSAY, MODEL OSR4K229
K010812 · LAR
Syva Co., Dade Behring, Inc.
Chemistry · 25d
Cleared Jan 22, 2001
EMIT 2000 TOBRAMYCIN ASSAY EMIT 2000 TOBRAMYCIN CALIBRATORS
K003341 · KLB
Syva Co., Dade Behring, Inc.
Chemistry · 89d
Cleared Mar 27, 2000
SYVA EMIT 2000 THYROXINE ASSAY, CALIBRATORS
K000600 · KLI
Syva Co., Dade Behring, Inc.
Chemistry · 33d