FDA 510(k) Applications Submitted by MARTIN O'CONNOR
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K980531 |
02/11/1998 |
AIMSTEP PREGNANCY |
GERMAINE LABORATORIES, INC. |
| K981165 |
03/31/1998 |
AIMSTEP COMBO PREGNANCY, 1 TEST, 30 TEST, 50 TEST, 100 TEST |
GERMAINE LABORATORIES, INC. |
| K070929 |
04/03/2007 |
ACON U120 URINE ANALYZER, MODEL U111-101 |
ACON LABORATORIES, INC. |
| K991369 |
04/20/1999 |
ACCUDIP HOME PREGNANCY AND/OR AIMSTICK PREGNANCY |
GERMAINE LABORATORIES, INC. |
| K061559 |
06/05/2006 |
ACON URINALYSIS REAGENT STRIPS |
ACON LABORATORIES CO. |
| K051727 |
06/28/2005 |
AIMSTICK URINE REAGENT STRIPS |
GERMAINE LABORATORIES, INC. |
| K973825 |
10/07/1997 |
MIDSTREAM HOME REGNANCY TEST |
GERMAINE LABORATORIES, INC. |
| K974368 |
11/20/1997 |
AIMSTICK PBD PREGNANCY |
GERMAINE LABORATORIES, INC. |
| K974512 |
12/01/1997 |
AIMSTICK PBD COMBO PREGNANCY |
GERMAINE LABORATORIES, INC. |
| K961528 |
04/22/1996 |
SAS SHIGELLA BOYDII TYPE 11 ANTISERUM (3/100/1000ML) |
SA SCIENTIFIC, INC. |
| K961531 |
04/22/1996 |
SAS SHIGELLA BOYDII TYPE 13 ANTISERUM |
SA SCIENTIFIC, INC. |
| K961532 |
04/22/1996 |
SAS SHIGELLA FLEXNERI TYPE 5 ANTISERUM |
SA SCIENTIFIC, INC. |
| K961533 |
04/22/1996 |
SAS SHIGELLA FLEXNERI TYPE 6 ANTISERUM |
SA SCIENTIFIC, INC. |
| K961534 |
04/22/1996 |
SAS SHIGELLA SONNEI FORM I ANTISERUM (3/100/1000ML) |
SA SCIENTIFIC, INC. |
| K961535 |
04/22/1996 |
SAS SHIGELLA DYSENTERIAE GROUP A1 (8-10) ANTISERUM |
SA SCIENTIFIC, INC. |
| K961537 |
04/22/1996 |
SAS SHIGELLA SONNEI FORM II ANTISERUM |
SA SCIENTIFIC, INC. |
| K961538 |
04/22/1996 |
SAS SHIGELLA DYSENTERIAE TYPE 8 ANTISERUM |
SA SCIENTIFIC, INC. |
| K961539 |
04/22/1996 |
SAS SHIGELLA DYSENTERIAE TYPE 10 ANTISERUM |
SA SCIENTIFIC, INC. |
| K961540 |
04/22/1996 |
SAS SHIGELLA SONNEI GROUP D ANTISERUM |
SA SCIENTIFIC, INC. |
| K961541 |
04/22/1996 |
SAS SHIGELLA BOYDII TYPE 8 ANTISERUM |
SA SCIENTIFIC, INC. |
| K961542 |
04/22/1996 |
SAS SHIGELLA FLEXNERI TYPE 4 ANTISERUM |
SA SCIENTIFIC, INC. |
| K961543 |
04/22/1996 |
SAS SHIGELLA BOYDII TYPE 9 ANTISERUM |
SA SCIENTIFIC, INC. |
| K961546 |
04/22/1996 |
SAS SHIGELLA BOYDII GROUP C1/C1 (8-10) ANTISERUM |
SA SCIENTIFIC, INC. |
| K961547 |
04/22/1996 |
SAS SHIGELLA BOYDII TYPE 14 ANTISERUM |
SA SCIENTIFIC, INC. |
| K961548 |
04/22/1996 |
SAS SHIGELLA BOYDII TYPE 15 ANTISERUM |
SA SCIENTIFIC, INC. |
| K961549 |
04/22/1996 |
SAS SHIGELLA FLEXNERI TYPE 2 ANTISERUM |
SA SCIENTIFIC, INC. |
| K961551 |
04/22/1996 |
SAS SHIGELLA DYSENTERIAE TYPE 2 ANTISERUM |
SA SCIENTIFIC, INC. |
| K961553 |
04/22/1996 |
SAS SHIGELLA DYSENTERIAE TYPE 1 ANTISERUM |
SA SCIENTIFIC, INC. |
| K961554 |
04/22/1996 |
SAS SHIGELLA BOYDII TYPE 10 ANTISERUM |
SA SCIENTIFIC, INC. |
| K961556 |
04/22/1996 |
SAS SHIGELLA FLEXNERI TYPE 1 ANTISERUM |
SA SCIENTIFIC, INC. |
| K961558 |
04/22/1996 |
SAS SHIGELLA FLEXNERI TYPE 3 ANTISERUM |
SA SCIENTIFIC, INC. |
| K961559 |
04/22/1996 |
SAS SHIGELLA DYSENTERIAE TYPE 9 ANTISERUM |
SA SCIENTIFIC, INC. |
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