FDA 510(k) Applications Submitted by LUANN OCHS
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K981632 |
05/08/1998 |
ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM LIQUID TOTAL BILIRUBIN REAGENT |
ROCHE DIAGNOSTICS/BOEHRINGER MANNHEIM GMBH |
| K981883 |
05/29/1998 |
ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM CORPORATION LIQUID DIRECT BILIRUBIN REAGENT, CATALOG NUMBER 1877844 |
BOEHRINGER MANNHEIM CORP. |
| K011684 |
05/30/2001 |
INFLUENZA A/B RAPID TEST, CAT NO 2158 663 |
ROCHE DIAGNOSTICS CORP. |
| K992492 |
07/26/1999 |
PTN TEST CARTRIDGES FOR COAGUCHEK PRO SYSTEM, PTN CONTROLS FOR COAGUCHEK PRO SYSTEM |
ROCHE DIAGNOSTICS CORP. |
| K992851 |
08/24/1999 |
ACT TEST CATRIDGES FOR COAGUCHEK PRO SYSTEM, ACT CONTROLS FOR COAGUCHEK PRO SYSTEM |
ROCHE DIAGNOSTICS CORP. |
| K993048 |
09/10/1999 |
ROCHE DIAGNOSTICS INFLUENZA A/B RAPID TEST |
ROCHE DIAGNOSTICS CORP. |
| K983416 |
09/29/1998 |
ROCHE DIAGNOSTICS MAGNESIUM REAGENT, CAT# 1551353 |
BOEHRINGER MANNHEIM CORP. |
| K983892 |
11/03/1998 |
COAGUCHEK PRO SYSTEM, APTT TEST CARTRIDGES FOR COAGUCHEK PRO SYSTEM, APTT CONTROLS FOR COAGUCHEK PRO SYSTEM, COAGUCHEK P |
ROCHE DIAGNOSTICS/BOEHRINGER MANNHEIM GMBH |
| K004010 |
12/26/2000 |
ACCU-CHEK COMPACT SYSTEM, ACCU-CHEK COMPACT TEST STRIPS, ACCU-CHEK COMPACT COMPACT CONTROLS |
ROCHE DIAGNOSTICS CORP. |
|
|
