FDA 510(k) Applications Submitted by MELISSA M TRAYLOR, RAC
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K000128 |
01/18/2000 |
HARDYDISK, CEFAZOLIN, 30MCG |
HARDY DIAGNOSTICS |
| K000130 |
01/18/2000 |
HARDYDISK, NALIDIXIC ACID, 30MCG |
HARDY DIAGNOSTICS |
| K000203 |
01/21/2000 |
HARDYDISK, KANAMYCIN, 30MCG |
HARDY DIAGNOSTICS |
| K000201 |
01/21/2000 |
HARDYDISK, STREPTOMYCIN 10MCG |
HARDY DIAGNOSTICS |
| K001728 |
06/07/2000 |
HARDY DISK CLARITHROMYCIN, 15MCG |
HARDY DIAGNOSTICS |
| K000022 |
01/04/2000 |
HARDYDISK CEFAMANDOLE, 30MCG |
HARDY DIAGNOSTICS |
| K960075 |
01/11/1996 |
CHROMAGAR CANDIDA |
HARDY DIAGNOSTICS |
| K000175 |
01/20/2000 |
HARDYDISK TICARILLIN 75MCG |
HARDY DIAGNOSTICS |
| K000182 |
01/20/2000 |
HARDYDISK TOBRAMYCIN, 10MCG |
HARDY DIAGNOSTICS |
| K000183 |
01/20/2000 |
HARDYDISK, PIPERACILLIN, 100MCG |
HARDY DIAGNOSTICS |
| K000258 |
01/28/2000 |
HARDYDISK, CIPROFLOXACIN, 5MCG |
HARDY DIAGNOSTICS |
| K000259 |
01/28/2000 |
HARDYDISK, CEFTAZIDIME, 30MCG |
HARDY DIAGNOSTICS |
| K000261 |
01/28/2000 |
HARDYDISK, PIPERACILLIN/TAZOBACTAM, 110MCG |
HARDY DIAGNOSTICS |
| K000268 |
01/28/2000 |
HARDYDISK, AMPICILLIN, 10MCG |
HARDY DIAGNOSTICS |
| K000271 |
01/28/2000 |
HARDYDISK, SULFA/TRIMETH |
HARDY DIAGNOSTICS |
| K000272 |
01/28/2000 |
HARDYDISK, NITROFURANTOIN |
HARDY DIAGNOSTICS |
| K000302 |
02/01/2000 |
HARDY DISK, PENICILLIN, 10 UNITS |
HARDY DIAGNOSTICS |
| K000304 |
02/01/2000 |
HARDYDISK, TETRACYCLINE 30MCG |
HARDY DIAGNOSTICS |
| K000305 |
02/01/2000 |
HARDYDISK, CEFOXITIN, 30MCG |
HARDY DIAGNOSTICS |
| K000440 |
02/10/2000 |
HARDYDISK CEFTRIAXONE 30MCG |
HARDY DIAGNOSTICS |
| K000509 |
02/15/2000 |
HARDYDISK, VANCOMYCIN 30MCG |
HARDY DIAGNOSTICS |
| K000524 |
02/16/2000 |
HARDYDISK, CEFOTAXIME 30MCG |
HARDY DIAGNOSTICS |
| K000525 |
02/16/2000 |
HARDYDISK OFLOXACIN 5MCG |
HARDY DIAGNOSTICS |
| K000526 |
02/16/2000 |
HARDYDISK, CEPHALOTHIN 30MCG |
HARDY DIAGNOSTICS |
| K011086 |
04/10/2001 |
HARDYDISK BACITRACIN, 10MCG, MODEL Z927 |
HARDY DIAGNOSTICS |
| K001487 |
05/12/2000 |
HARDYDISK CINOXACIN, 100 MCG |
HARDY DIAGNOSTICS |
| K001489 |
05/12/2000 |
HARDYDISK CEFOPERAZONE, 75 MCG |
HARDY DIAGNOSTICS |
| K001490 |
05/12/2000 |
HARDYDISK CEFONICID, 30 MCG |
HARDY DIAGNOSTICS |
| K002367 |
08/03/2000 |
HARDY DISK CEFTIZOXIME, 30MCG |
HARDY DIAGNOSTICS |
| K002368 |
08/03/2000 |
HARDYDISK STREPTOMYCIN, 300MCG |
HARDY DIAGNOSTICS |
| K002369 |
08/03/2000 |
HARDYDISK GENTAMICIN, 120MCG |
HARDY DIAGNOSTICS |
| K002661 |
08/25/2000 |
HARDYDISK CEFOTETAN, 30MCG |
HARDY DIAGNOSTICS |
| K002662 |
08/25/2000 |
HARDYDISK CLINDAMYCIN, 2MCG |
HARDY DIAGNOSTICS |
| K002663 |
08/25/2000 |
HARDYDISK NETILMICIN, 30MCG |
HARDY DIAGNOSTICS |
| K002664 |
08/25/2000 |
HARDYDISK LEVOFLOXACIN, 5MCG |
HARDY DIAGNOSTICS |
| K002656 |
08/25/2000 |
HARDYDISK CEFUROXIME, 30MCG |
HARDY DIAGNOSTICS |
| K002660 |
08/25/2000 |
HARDYDISK LOMEFLOXACIN, 10MCG |
HARDY DIAGNOSTICS |
| K964560 |
11/13/1996 |
BHI W/VANCOMYCIN AGAR |
HARDY DIAGNOSTICS |
| K003537 |
11/16/2000 |
HARDYDISK RIFAMPIN, 5MCG |
HARDY DIAGNOSTICS |
| K003536 |
11/16/2000 |
HARDYDISK NAFCILLIN, 1 MCG |
HARDY DIAGNOSTICS |
| K003554 |
11/17/2000 |
HARDYDISK TRIMETHOPRIM 5MCG |
HARDY DIAGNOSTICS |
| K003556 |
11/17/2000 |
HARDYDISK AMOXICILLIN/CLAVULANIC ACID, 20/10MCG |
HARDY DIAGNOSTICS |
| K993994 |
11/24/1999 |
HARDYDISK AZITHROMYCIN 15MCG |
HARDY DIAGNOSTICS |
| K994046 |
11/29/1999 |
HARDYDISK CEFACLOR 30MCG |
HARDY DIAGNOSTICS |
| K994051 |
11/30/1999 |
HARDYDISK DOXYCYCLINE, 30MCG |
HARDY DIAGNOSTICS |
| K003686 |
11/30/2000 |
HARDYDISK TICARCILLIN/CLAVULANIC ACID, 85MCG |
HARDY DIAGNOSTICS |
| K003690 |
11/30/2000 |
HARDYDISK SULFISOXAZOLE |
HARDY DIAGNOSTICS |
| K994063 |
12/01/1999 |
HARDYDISK AZTREONAM, 30MCG |
HARDY DIAGNOSTICS |
| K994067 |
12/01/1999 |
HARDY DISK AMPICILLIN/SULBACTAM |
HARDY DIAGNOSTICS |
| K994089 |
12/03/1999 |
HARDYDISK CHLORAMPHENICOL, 30MCG |
HARDY DIAGNOSTICS |
| K994091 |
12/03/1999 |
HARDYDISK GENTAMICIN, 10MCG |
HARDY DIAGNOSTICS |
| K994129 |
12/07/1999 |
HARDYDISK CEFIXIME, 5MCG |
HARDY DIAGNOSTICS |
| K994132 |
12/07/1999 |
HARDYDISK IMIPENEM, 10MCG |
HARDY DIAGNOSTICS |
| K994134 |
12/07/1999 |
HARDYDISK OXACILLIN, 1MCG |
HARDY DIAGNOSTICS |
| K994135 |
12/07/1999 |
HARDYDISK ERYTHROMYCIN, 15MCG |
HARDY DIAGNOSTICS |
| K994150 |
12/08/1999 |
HARDYDISK NORFLOXACIN, 10MCG |
HARDY DIAGNOSTICS |
| K994212 |
12/14/1999 |
HARDYDISK MEZLOCILLIN 75MCG |
HARDY DIAGNOSTICS |
| K960996 |
03/12/1996 |
M. CAT BUTYRATE DISK |
HARDY DIAGNOSTICS |
| K961191 |
03/26/1996 |
COLISCREEN |
HARDY DIAGNOSTICS |
| K011384 |
05/07/2001 |
HARDYDISK NOVOBIOCIN, 30MCG, MODEL Z883 |
HARDY DIAGNOSTICS |
| K011385 |
05/07/2001 |
HARDKYDISK NEOMYCIN, 30 MCG |
HARDY DIAGNOSTICS |
| K003532 |
11/16/2000 |
HARDY DISK, CEFPODOXINE, 10MCG |
HARDY DIAGNOSTICS |
| K993993 |
11/24/1999 |
HARDYDISK AMIKACIN 30MCG |
HARDY DIAGNOSTICS |
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