FDA 510(k) Applications Submitted by SYVA CO., DADE BEHRING, INC.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K011164 |
04/16/2001 |
MODIFICATION TO THE EMIT II PLUS METHAQUALONE ASSAY, MODEL OSR9Q229 |
SYVA CO., DADE BEHRING, INC. |
| K011620 |
05/25/2001 |
EMIT 2000 N-ACETYLPROCAINAMIDE ASSAY, MODEL OSR4N229 |
SYVA CO., DADE BEHRING, INC. |
| K011306 |
04/30/2001 |
EMIT II PLUS BENZODIAZEPINE ASSAY, MODEL 0SR9F229 |
SYVA CO., DADE BEHRING, INC. |
| K003341 |
10/25/2000 |
EMIT 2000 TOBRAMYCIN ASSAY EMIT 2000 TOBRAMYCIN CALIBRATORS |
SYVA CO., DADE BEHRING, INC. |
| K000600 |
02/23/2000 |
SYVA EMIT 2000 THYROXINE ASSAY, CALIBRATORS |
SYVA CO., DADE BEHRING, INC. |
| K010960 |
03/30/2001 |
EMIT II PLUS ETHYL ALCOHOL ASSAY, MODEL OSR9K229 |
SYVA CO., DADE BEHRING, INC. |
| K011161 |
04/16/2001 |
MODIFICATION TO THE EMIT II PLUS PHENCYCLIDINE ASSAY, MODEL OSR9J229 |
SYVA CO., DADE BEHRING, INC. |
| K011162 |
04/16/2001 |
MODIFICATION TO THE EMIT II PLUS COCAINE METABOLITE ASSAY |
SYVA CO., DADE BEHRING, INC. |
| K011163 |
04/16/2001 |
MODIFICATION TO THE EMIT II PLUS PROPOXYPHENE ASSAY, MODEL OSR9G229 |
SYVA CO., DADE BEHRING, INC. |
| K011289 |
04/27/2001 |
EMIT II PLUS OPIATE ASSAY, MODEL OSR9B229 |
SYVA CO., DADE BEHRING, INC. |
| K011605 |
05/24/2001 |
EMIT 2000 QUINIDINE ASSAY, MODEL OSR4Q229 |
SYVA CO., DADE BEHRING, INC. |
| K011920 |
06/20/2001 |
EMIT 2000 DIGOXIN ASSAY, MODEL OSR4H229 |
SYVA CO., DADE BEHRING, INC. |
| K010812 |
03/19/2001 |
EMIT 2000 PROCAINAMIDE ASSAY, MODEL OSR4K229 |
SYVA CO., DADE BEHRING, INC. |
| K010814 |
03/19/2001 |
EMIT 2000 CARBAMAZEPINE ASSAY, MODEL OSR4F229 |
SYVA CO., DADE BEHRING, INC. |
| K010934 |
03/28/2001 |
EMIT II PLUS BARBITUATE ASSAY, MODEL 0SR9D0229 |
SYVA CO., DADE BEHRING, INC. |
| K010962 |
03/30/2001 |
EMIT II PLUS METHADONE ASSAY, MODEL OSRE229 |
SYVA CO., DADE BEHRING, INC. |
| K010984 |
04/02/2001 |
EMIT 2000 GENTAMICIN PLUS ASSAY |
SYVA CO., DADE BEHRING, INC. |
| K011166 |
04/16/2001 |
MODIFICATION TO EMIT 2000 THEOPHYLLINE ASSAY, MODEL OSR 4P229 |
SYVA CO., DADE BEHRING, INC. |
| K011300 |
04/30/2001 |
EMIT II PLUS CANNABINOID ASSAY, MODEL OSR9N229 |
SYVA CO., DADE BEHRING, INC. |
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