FDA 510(k) Applications Submitted by DAVID W GATES
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K961148 |
03/21/1996 |
CEFEPIME DISPANS-O-DISC (CEFEPLIME - 30MCG) |
DIFCO LABORATORIES, INC. |
| K963508 |
09/03/1996 |
DISPENS-O-DISC MEROPENEM |
DIFCO LABORATORIES, INC. |
| K971120 |
03/27/1997 |
DISPENS-O-DISC (TM) LEVOFLOXACIN |
DIFCO LABORATORIES, INC. |
| K971211 |
03/27/1997 |
DISPENS-O-DISC SPARFLOXACIN |
DIFCO LABORATORIES, INC. |
| K101852 |
07/01/2010 |
CHEM VELOCITY AUTOMATED URINE CHEMISTRY SYSTEM, STRIPS AND CALCHEK KIT |
IRIS INTERNATIONAL INC., A DIVISION OF IRIS IRIS I |
| K954783 |
10/17/1995 |
DRYSLIDE CARTARRHALIS |
DIFCO LABORATORIES, INC. |
| K954784 |
10/17/1995 |
DRYSIDE NEISSERIA |
DIFCO LABORATORIES, INC. |
| K150617 |
03/10/2015 |
cobas HSV 1 and 2 Test |
ROCHE MOLECULAR SYSTEMS, INC. |
| K163184 |
11/14/2016 |
cobas« CT/NG v2.0 Test |
Roche Molecular Systems, Inc. |
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