FDA 510(k) Applications Submitted by MARIA FEIJOO
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K961436 |
04/15/1996 |
ABUSCREEN ONLINE LSD REAGENT (90 ML TEST KIT) |
ROCHE DIAGNOSTIC SYSTEMS, INC. |
| K961620 |
04/26/1996 |
ABISCREEN ONLINE FOR CANNABINOIDS - ES 50/100 |
ROCHE DIAGNOSTIC SYSTEMS, INC. |
| K961674 |
05/01/1996 |
ROCHE UNIMATE FRUCTOSAMINE REAGENT |
ROCHE DIAGNOSTIC SYSTEMS, INC. |
| K961726 |
05/03/1996 |
ABUSCREEN ONLINE CANNABINOIDS CALIBRATION PACK 20 |
ROCHE DIAGNOSTIC SYSTEMS, INC. |
| K961824 |
05/10/1996 |
COBAS INTEGRA REAGENT CASSETTES FOR ALBUMIN, HBALC AND DIGOXIN |
ROCHE DIAGNOSTIC SYSTEMS, INC. |
| K962280 |
06/13/1996 |
ABUSCREEN ONLINE POSITIVE CONTROL / 1.5X CALIBRATOR |
ROCHE DIAGNOSTIC SYSTEMS, INC. |
| K972250 |
06/16/1997 |
ROCHE COBAS INTEGRA REAGENT CASSETTES & ANCILLARY REAGENTS |
ROCHE DIAGNOSTIC SYSTEMS, INC. |
| K962411 |
06/21/1996 |
ONTRAK TESTCUP AMPHETAMINES |
ROCHE DIAGNOSTIC SYSTEMS, INC. |
| K982848 |
08/12/1998 |
COBAS INTEGRA LDL DIRECT REAGENT CASSETTE ROCHE CALIBRATOR LDL DIRECT |
ROCHE DIAGNOSTIC SYSTEMS, INC. |
| K953847 |
08/16/1995 |
ROCHE REAGENT FOR GLUCOSE |
ROCHE DIAGNOSTIC SYSTEMS, INC. |
| K973284 |
09/02/1997 |
COBAS INTEGRA HDL-CHOLESTEROL DIRECT |
ROCHE DIAGNOSTIC SYSTEMS, INC. |
| K983174 |
09/10/1998 |
ONTRAK TESTSTIK FOR BARBITURATES, ONTRAK TESTSTIK FOR BENZODIAZEPINES |
ROCHE DIAGNOSTIC SYSTEMS, INC. |
| K983387 |
09/25/1998 |
ONTRAK TESTCUP AND TESTSTIK CONTROLS |
ROCHE DIAGNOSTIC SYSTEMS, INC. |
| K983555 |
10/13/1998 |
ABUSCREEN ONLINE BENZ 200 CALIBRATORS |
ROCHE DIAGNOSTIC SYSTEMS, INC. |
| K983556 |
10/13/1998 |
ABUSCREEN ONLINE BENZ 300 CALIBRATORS |
ROCHE DIAGNOSTIC SYSTEMS, INC. |
| K954992 |
10/31/1995 |
ROCHE COBAS INTEGRA REAGENT CASSETTES |
ROCHE DIAGNOSTIC SYSTEMS, INC. |
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