FDA 510(k) Applications Submitted by RHIGENE, INC.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K000336 |
02/03/2000 |
RHIGENE DSG-1 & DSG-3 ELISA TEST SYSTEM, MODEL 7680 E |
RHIGENE, INC. |
| K000749 |
03/08/2000 |
RHIGENE MESACUP2 TEST- SSA |
RHIGENE, INC. |
| K000750 |
03/08/2000 |
RHIGENE MESACUP2 TEST- SCL-70 |
RHIGENE, INC. |
| K000751 |
03/08/2000 |
RHIGENE MESACUP2 TEST- SSB |
RHIGENE, INC. |
| K000752 |
03/08/2000 |
RHIGENE MESACUP2 TEST- RNP |
RHIGENE, INC. |
| K000755 |
03/08/2000 |
RHIGENE MESACUP2 TEST- SM |
RHIGENE, INC. |
| K994071 |
12/02/1999 |
RHIGENE ANA ELISA TEST SYSTEM |
RHIGENE, INC. |
| K011068 |
04/09/2001 |
RHIGENE NDNA TEST SYSTEM FOR IMAGETITER, MODEL CL100L |
RHIGENE, INC. |
| K040586 |
03/05/2004 |
MESACUP TEST MPO, MODEL 11053 |
RHIGENE, INC. |
| K040711 |
03/18/2004 |
MESACUP TEST PR-3 |
RHIGENE, INC. |
| K031308 |
04/24/2003 |
RHIGENE MESACUP-2 ANTI-MITOCHONDRIA M2 TEST, MODEL 10760 |
RHIGENE, INC. |
| K033528 |
11/07/2003 |
MESACUP-2 TEST JO-1, MODEL 10756 |
RHIGENE, INC. |
| K040200 |
01/29/2004 |
MESACUP-2 TEST CENP-B |
RHIGENE, INC. |
| K022017 |
06/20/2002 |
RHIGENE MESACUP-2 TEST RNP, MODEL M7741 |
RHIGENE, INC. |
| K022018 |
06/20/2002 |
RHIGENE ANA ELISA TEST SYSTEM, MODEL K7560 |
RHIGENE, INC. |
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