FDA 510(k) Applications Submitted by SUSAN COLLINS
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K971045 |
03/21/1997 |
BASIS FLEXIBLE TIP DIGITAL THERMOMETER |
POLYMEDICA INDUSTRIES, 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. |
| K011347 |
05/02/2001 |
EMIT 2000 PHENYTOIN ASSAY, MODEL 0SR4A229 |
SYVA CO. |
| K011528 |
05/17/2001 |
EMIT 2000 PHENOBARBITAL ASSAY, MODEL OSR4D229 |
SYVA CO. |
| K011605 |
05/24/2001 |
EMIT 2000 QUINIDINE ASSAY, MODEL OSR4Q229 |
SYVA CO., DADE BEHRING, INC. |
| K011878 |
06/15/2001 |
EMIT (R) TOX SALICYLIC ASSAY, MODEL 7SO19UL, EMIT (R) TOX SALICYLIC ACID CALIBRATORS, MODEL 7S109UL |
SYVA CO. |
| K011920 |
06/20/2001 |
EMIT 2000 DIGOXIN ASSAY, MODEL OSR4H229 |
SYVA CO., DADE BEHRING, INC. |
| 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. |
|
|
