Syva Co.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
448
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K011878EMIT (R) TOX SALICYLIC ASSAY, MODEL 7SO19UL, EMIT (R) TOX SALICYLIC ACID CALIBRATORS, MODEL 7S109ULAugust 13, 2001
K012257EMIT II PLUS MONOCLONAL AMPHETAMINE/METHAMPHETAMINE ASSAY MODEL OSR9C229August 3, 2001
K011947EMIT 2000 VALPROIC ACID ASSAY, MODEL OSR4G229ULJuly 2, 2001
K011528EMIT 2000 PHENOBARBITAL ASSAY, MODEL OSR4D229June 6, 2001
K011347EMIT 2000 PHENYTOIN ASSAY, MODEL 0SR4A229May 17, 2001
K993980SYVA EMIT II PLUS ETHYL ALCOHOL ASSAY, MODELS 9K309UL/9K409ULFebruary 1, 2000
K993981SYVA EMIT II PLUS PROPOXYPHENE ASSAY, MODELS 9G029UL/9G129ULFebruary 1, 2000
K993028ABBOTT AEROSET CARBAMAZEPINE ASSAY AND CALIBRATORS; MODELS 1E12 AND 6E90January 27, 2000
K993031ABBOTT AEROSET PHENOBARBITAL ASSEY AND CALIBRATORS;MODELS 1E08 AND 5F54January 27, 2000
K993029ABBOTT AEROSET THEOPHYLLINE ASSAY AND CALIBRATORS; MODELS 1E09 AND 6E89January 27, 2000
K993987SYVA EMIT II PLUS BARBITURATE ASSAY, MODEL 9D029UL/9D129ULJanuary 27, 2000
K993985SYVA EMIT II PLUS BENZODIAZEPINE ASSAY, MODELS 9F029UL/9F129ULJanuary 27, 2000
K993988SYVA EMIT II PLUS COCAINE METABOLITE ASSAY, MODEL 9H029ULJanuary 27, 2000
K993026ABBOT AEROSET PHENYTOIN ASSAY & ABBOT AEROSET PHENYTOIN CALIBRATORSJanuary 27, 2000
K993986SYVA EMIT II PLUS METHAQUALONE ASSAY, MODEL 9Q029UL/9Q129ULJanuary 27, 2000
K993982SYVA EMIT II PLUS AMPHETAMINE/METHAMPHETAMINE ASSAY 9C029UL/9C129ULJanuary 27, 2000
K993983SYVA EMIT II PLUS PHENCYCLIDINE ASSAY, MODEL 9J029ULJanuary 27, 2000
K994005SYVA EMIT II PLUS METHADONE ASSAY, MODELS 9E029UL/9E129ULJanuary 20, 2000
K993984SYVA EMIT II PLUS CANNABINOID ASSAY, MODELS 9N029UL/9N129ULJanuary 18, 2000
K993755EMIT CALIBRATER/CONTROL LEVEL 0, LEVEL 1, LEVEL 2, LEVEL 3, LEVEL 4, LEVEL 5December 21, 1999