Roche Diagnostic Systems, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 296
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K983698 | MODIFICATION TO ABUSCREEN ONLINE BARBITURATES | May 3, 1999 |
| K983702 | MODIFICATION TO ABUSCREEN ONLINE FOR BENZOIDIAZEPINES | February 11, 1999 |
| K983704 | MODIFICATION TO ABUSCREEN ONLINE FOR PHENCYCLIDINE | February 10, 1999 |
| K983556 | ABUSCREEN ONLINE BENZ 300 CALIBRATORS | December 15, 1998 |
| K983555 | ABUSCREEN ONLINE BENZ 200 CALIBRATORS | December 15, 1998 |
| K983699 | MODIFICATION TO ABUSCREEN ONLINE FOR AMPHETAMINES | December 11, 1998 |
| K983703 | MODIFICATION TO ABUSCREEN ONLINE FOR METHADONE | December 11, 1998 |
| K983701 | MODIFICATION TO ABUSCREEN ONLINE FOR CANNABINOIDS | December 11, 1998 |
| K983697 | MODIFICATION TO ABUSCREEN ONLINE COCAINE METABOLITE | December 11, 1998 |
| K983700 | MODIFICATION TO ABUSCREEN ONLINE FOR PROPOXYPHENE | December 11, 1998 |
| K983388 | ONTRAK TESTCUP-ER | November 18, 1998 |
| K983174 | ONTRAK TESTSTIK FOR BARBITURATES, ONTRAK TESTSTIK FOR BENZODIAZEPINES | November 18, 1998 |
| K983387 | ONTRAK TESTCUP AND TESTSTIK CONTROLS | October 9, 1998 |
| K982848 | COBAS INTEGRA LDL DIRECT REAGENT CASSETTE ROCHE CALIBRATOR LDL DIRECT | October 1, 1998 |
| K982382 | COBAS INTEGRA REAGENT CASSETTES | September 28, 1998 |
| K981897 | ROCHE COBAS INTEGRA ALKALINE PHOSPHATASE IFCC LIQUID REAGENT CASSETTE, ROCHE COBAS INTEGRA PANCREATI | August 26, 1998 |
| K982087 | ROCHE CRP T CONTROL N | August 18, 1998 |
| K982551 | ROCHE C0BAS INTEGRA SERUM BARBITURATES REAGENT CASSETTE, ABUSCREEB ONLINE SERUM BARBITURATES CALIBRA | August 18, 1998 |
| K980996 | COBAS INTEGRA CARBON DIOXIDE (CO2-S), COBAS INTEGRA GLUCOSE HK LIQUID (GLULF) | June 5, 1998 |
| K981584 | ABUSCREEN ONLINE FOR CANNABINOIDS (100 TEST KIT) | May 28, 1998 |