FDA 510(k) Applications Submitted by SYVA CO.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K993028 |
09/09/1999 |
ABBOTT AEROSET CARBAMAZEPINE ASSAY AND CALIBRATORS; MODELS 1E12 AND 6E90 |
SYVA CO. |
| K993029 |
09/09/1999 |
ABBOTT AEROSET THEOPHYLLINE ASSAY AND CALIBRATORS; MODELS 1E09 AND 6E89 |
SYVA CO. |
| K993031 |
09/09/1999 |
ABBOTT AEROSET PHENOBARBITAL ASSEY AND CALIBRATORS;MODELS 1E08 AND 5F54 |
SYVA CO. |
| K993755 |
11/05/1999 |
EMIT CALIBRATER/CONTROL LEVEL 0, LEVEL 1, LEVEL 2, LEVEL 3, LEVEL 4, LEVEL 5 |
SYVA CO. |
| K993980 |
11/24/1999 |
SYVA EMIT II PLUS ETHYL ALCOHOL ASSAY, MODELS 9K309UL/9K409UL |
SYVA CO. |
| K993981 |
11/24/1999 |
SYVA EMIT II PLUS PROPOXYPHENE ASSAY, MODELS 9G029UL/9G129UL |
SYVA CO. |
| K993982 |
11/24/1999 |
SYVA EMIT II PLUS AMPHETAMINE/METHAMPHETAMINE ASSAY 9C029UL/9C129UL |
SYVA CO. |
| K993983 |
11/24/1999 |
SYVA EMIT II PLUS PHENCYCLIDINE ASSAY, MODEL 9J029UL |
SYVA CO. |
| K993984 |
11/24/1999 |
SYVA EMIT II PLUS CANNABINOID ASSAY, MODELS 9N029UL/9N129UL |
SYVA CO. |
| K993985 |
11/24/1999 |
SYVA EMIT II PLUS BENZODIAZEPINE ASSAY, MODELS 9F029UL/9F129UL |
SYVA CO. |
| K993986 |
11/24/1999 |
SYVA EMIT II PLUS METHAQUALONE ASSAY, MODEL 9Q029UL/9Q129UL |
SYVA CO. |
| K993987 |
11/24/1999 |
SYVA EMIT II PLUS BARBITURATE ASSAY, MODEL 9D029UL/9D129UL |
SYVA CO. |
| K993988 |
11/24/1999 |
SYVA EMIT II PLUS COCAINE METABOLITE ASSAY, MODEL 9H029UL |
SYVA CO. |
| K994005 |
11/24/1999 |
SYVA EMIT II PLUS METHADONE ASSAY, MODELS 9E029UL/9E129UL |
SYVA CO. |
| K984232 |
11/25/1998 |
MODIFICATION OF EMIT D.A.U. OPIATES ASSAY |
SYVA CO. |
| K993026 |
09/09/1999 |
ABBOT AEROSET PHENYTOIN ASSAY & ABBOT AEROSET PHENYTOIN CALIBRATORS |
SYVA CO. |
| K011347 |
05/02/2001 |
EMIT 2000 PHENYTOIN ASSAY, MODEL 0SR4A229 |
SYVA CO. |
| K011528 |
05/17/2001 |
EMIT 2000 PHENOBARBITAL ASSAY, MODEL OSR4D229 |
SYVA CO. |
| K011878 |
06/15/2001 |
EMIT (R) TOX SALICYLIC ASSAY, MODEL 7SO19UL, EMIT (R) TOX SALICYLIC ACID CALIBRATORS, MODEL 7S109UL |
SYVA CO. |
| K011947 |
06/21/2001 |
EMIT 2000 VALPROIC ACID ASSAY, MODEL OSR4G229UL |
SYVA CO. |
| K012257 |
07/18/2001 |
EMIT II PLUS MONOCLONAL AMPHETAMINE/METHAMPHETAMINE ASSAY MODEL OSR9C229 |
SYVA CO. |
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