FDA 510(k) Applications Submitted by PAUL L ROGERS
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K982210 |
06/23/1998 |
MODIFICATION OF SYVA MICROTRAK II CHLAMYDIA EIA |
DADE BEHRING, INC. |
| K000600 |
02/23/2000 |
SYVA EMIT 2000 THYROXINE ASSAY, CALIBRATORS |
SYVA CO., DADE BEHRING, INC. |
| K972116 |
06/05/1997 |
VON WILLEBRAND REAGENT |
BEHRING DIAGNOSTICS, INC. |
| K962519 |
06/27/1996 |
EMIT 2000 GENTAMICIN ASSAY AND CALIBRATORS |
BEHRING DIAGNOSTICS, INC. |
| K002551 |
08/17/2000 |
EMIT 2000 VALPROIC ACID ASSAY, EMIT 2000 VALPROIC ACID CALIBRATORS, MODEL 4G019UL, 4G109UL |
DADE BEHRING, INC. |
| K002974 |
08/17/2000 |
EMIT TOX ACETAMINOPHEN ASSAY, MODEL 7A319UL; EMIT TOX ECETAMINOPHEN CALIBRATORS, MODEL 7A409UL |
DADE BEHRING, INC. |
| 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. |
| K962968 |
07/30/1996 |
PROC APC ASSAY, PROC CONTROL PLASMA |
BEHRING DIAGNOSTICS, INC. |
| K993026 |
09/09/1999 |
ABBOT AEROSET PHENYTOIN ASSAY & ABBOT AEROSET PHENYTOIN CALIBRATORS |
SYVA CO. |
| K970431 |
02/04/1997 |
BEHRING COAGULATION SYSTEM |
BEHRING DIAGNOSTICS, INC. |
| K970645 |
02/20/1997 |
BC THROMBIN REAGENT |
BEHRING DIAGNOSTICS, INC. |
| K955448 |
11/29/1995 |
EMIT II LSD ASSAY, EMIT LSD CALIBRATORS & EMIT LSD CONTROLS |
BEHRING DIAGNOSTICS, INC. |
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