FDA 510(k) Applications Submitted by RITA SMITH
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K981584 |
05/04/1998 |
ABUSCREEN ONLINE FOR CANNABINOIDS (100 TEST KIT) |
ROCHE DIAGNOSTIC SYSTEMS, INC. |
| K981585 |
05/04/1998 |
ABUSCREEN ONLINE FOR CANNABINOIDS (1000 TEST KIT) |
ROCHE DIAGNOSTIC SYSTEMS, INC. |
| K981897 |
06/01/1998 |
ROCHE COBAS INTEGRA ALKALINE PHOSPHATASE IFCC LIQUID REAGENT CASSETTE, ROCHE COBAS INTEGRA PANCREATIC A-AMYLASE EPS REAE |
ROCHE DIAGNOSTIC SYSTEMS, INC. |
| K962165 |
06/04/1996 |
COBAS-FP TDM CALIBRATION VERIFICATION TEST SET |
ROCHE DIAGNOSTIC SYSTEMS, INC. |
| K962231 |
06/10/1996 |
COBAS CORE IMMUNOCHEMISTRY SYSTEM |
ROCHE DIAGNOSTIC SYSTEMS, INC. |
| K982087 |
06/15/1998 |
ROCHE CRP T CONTROL N |
ROCHE DIAGNOSTIC SYSTEMS, INC. |
| K982382 |
07/08/1998 |
COBAS INTEGRA REAGENT CASSETTES |
ROCHE DIAGNOSTIC SYSTEMS, INC. |
| K982551 |
07/22/1998 |
ROCHE C0BAS INTEGRA SERUM BARBITURATES REAGENT CASSETTE, ABUSCREEB ONLINE SERUM BARBITURATES CALIBRATORS, ROCHE COBAS IN |
ROCHE DIAGNOSTIC SYSTEMS, INC. |
| K963627 |
09/11/1996 |
(MODIFIED VERSION) INTEGRA ION SELECTIVE ELECTRODE (ISE) MODULE |
ROCHE DIAGNOSTIC SYSTEMS, INC. |
| K983388 |
09/25/1998 |
ONTRAK TESTCUP-ER |
ROCHE DIAGNOSTIC SYSTEMS, INC. |
| K983697 |
10/21/1998 |
MODIFICATION TO ABUSCREEN ONLINE COCAINE METABOLITE |
ROCHE DIAGNOSTIC SYSTEMS, INC. |
| K983698 |
10/21/1998 |
MODIFICATION TO ABUSCREEN ONLINE BARBITURATES |
ROCHE DIAGNOSTIC SYSTEMS, INC. |
| K983699 |
10/21/1998 |
MODIFICATION TO ABUSCREEN ONLINE FOR AMPHETAMINES |
ROCHE DIAGNOSTIC SYSTEMS, INC. |
| K983700 |
10/21/1998 |
MODIFICATION TO ABUSCREEN ONLINE FOR PROPOXYPHENE |
ROCHE DIAGNOSTIC SYSTEMS, INC. |
| K983701 |
10/21/1998 |
MODIFICATION TO ABUSCREEN ONLINE FOR CANNABINOIDS |
ROCHE DIAGNOSTIC SYSTEMS, INC. |
| K983702 |
10/21/1998 |
MODIFICATION TO ABUSCREEN ONLINE FOR BENZOIDIAZEPINES |
ROCHE DIAGNOSTIC SYSTEMS, INC. |
| K983703 |
10/21/1998 |
MODIFICATION TO ABUSCREEN ONLINE FOR METHADONE |
ROCHE DIAGNOSTIC SYSTEMS, INC. |
| K983704 |
10/21/1998 |
MODIFICATION TO ABUSCREEN ONLINE FOR PHENCYCLIDINE |
ROCHE DIAGNOSTIC SYSTEMS, INC. |
| K964422 |
11/05/1996 |
ONTRAK TESTTCUP COLLECTION/URINALYSIS PANEL |
ROCHE DIAGNOSTIC SYSTEMS, INC. |
| K964457 |
11/06/1996 |
ROCHE COBAS IBTEGRA REAGENT CASSETTES |
ROCHE DIAGNOSTIC SYSTEMS, INC. |
| K964670 |
11/21/1996 |
ROCHE COBAS-FP REAGENTS FOR TOBRAMYCIN |
ROCHE DIAGNOSTIC SYSTEMS, INC. |
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