FDA 510(k) Applications Submitted by RONALD G LEONARDI, PH.D.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K991330 |
04/19/1999 |
MEDI-CULT LIQUID PARAFFIN |
MEDICULT A/S |
| K080172 |
01/24/2008 |
BLASTASSIST WITHOUT PHENOL RED, MODEL REF 1215, BLASTASSIST WITH PHENOL RED, MODEL REF 1216 |
MEDICULT A/S |
| K100367 |
02/12/2010 |
MEDICULT VITRIFICATION COOLING/WARMING, MODEL REF: 1228, 1229 |
ORIGIO A/S |
| K030490 |
02/14/2003 |
ISM1+, IMS2+, AND UTM+ |
MEDICULT A/S |
| K080473 |
02/21/2008 |
EMBRYOASSIST AND EMBRYOASSIST WITH PHENOL RED |
MEDICULT A/S |
| K030655 |
03/03/2003 |
HOLOTC RIA |
AXIS-SHIELD BIOCHEMICALS, ASA |
| K050574 |
03/07/2005 |
AFINION HBALC |
AXIS-SHIELD POC AS |
| K980907 |
03/10/1998 |
AXIS HOMOCYSTEINE ENZYME IMMUNOASSAY |
AXIS BIOCHEMICALS, ASA |
| K060699 |
03/16/2006 |
SYNVITRO CUMULASE (HYALURONIDASE MEDIUM) |
MEDICULT A/S |
| K060983 |
04/10/2006 |
BIOPSY MEDIUM, MODEL REF 1062 |
MEDICULT A/S |
| K991279 |
04/14/1999 |
MEDI-CULT UNIVERSAL IVF-MEDIUM |
MEDICULT A/S |
| K991470 |
04/14/1999 |
MEDI-CULT ACIDIFIED TYRODES SOLUTION- MEDIUM; INTERNAL CATALOG NUMBERS (1060) |
MEDICULT A/S |
| K991471 |
04/14/1999 |
MEDI-CULT BLASTOCYST FREEZING & THAWING PACKS, INTERNAL CATALOG NUMBERS (1012, 1015) |
MEDICULT A/S |
| K991472 |
04/14/1999 |
MEDI-CULT EMBRYO FREEZING MEDIUM INTERNAL CATAGLOG NUMBERS 1079 |
MEDICULT A/S |
| K031228 |
04/18/2003 |
SYNVITRO HYADASE |
MEDICULT A/S |
| K991327 |
04/19/1999 |
MEDI-CULT FLUSHING MEDIUM |
MEDICULT A/S |
| K991329 |
04/19/1999 |
MEDI-CULT PVP MEDIUM, MEDI-CULT PVP CLINICAL GRADE |
MEDICULT A/S |
| K991331 |
04/19/1999 |
MEDI-CULT M3 MEDIUM |
MEDICULT A/S |
| K991332 |
04/19/1999 |
MEDI-CULT SPERM PREPARATION - MEDIUM; |
MEDICULT A/S |
| K991333 |
04/19/1999 |
MEDI-CULT SPERM FREEZE MEDIUM |
MEDICULT A/S |
| K991334 |
04/19/1999 |
MEDI-CULT HYALURONIDASE; |
MEDICULT A/S |
| K061145 |
04/25/2006 |
SPERMSLOW |
MEDICULT A/S |
| K061309 |
05/10/2006 |
EMBRYOASSIST |
MEDICULT A/S |
| K031486 |
05/12/2003 |
BLASTFREEZE AND BLASTTHAW |
MEDICULT A/S |
| K041284 |
05/13/2004 |
MEDICULT IVM SYSTEM |
MEDICULT A/S |
| K071388 |
05/18/2007 |
GENTIAN CYSTATIN C IMMUNOASSAY |
GENTIAN AS |
| K001651 |
05/30/2000 |
BIO-RAD %CDT TIA |
AXIS-SHIELD BIOCHEMICALS, ASA |
| K081639 |
06/11/2008 |
ICSI CUMULASE |
MEDICULT A/S |
| K992274 |
07/06/1999 |
MODIFICATION TO IMX HOMOCYSTEINE |
AXIS BIOCHEMICALS, ASA |
| K992502 |
07/26/1999 |
AXIS %CDT TURBIDIMETRIC IMMUNOASSAY |
AXIS |
| K963111 |
08/12/1996 |
COATEST APC (TM) RESISTANCE V/COATEST APC (TM) RESISTANCE V S |
CHROMOGENIX AB |
| K003163 |
10/10/2000 |
SYNVITRO FLUSH |
MEDICULT A/S |
| K003156 |
10/10/2000 |
BLASTASSIST SYSTEM |
MEDICULT A/S |
| K003404 |
11/01/2000 |
SUPRASPERM SYSTEM |
MEDICULT A/S |
| K980812 |
03/03/1998 |
IMX HOMOCYSTEINE |
AXIS BIOCHEMICALS, ASA |
|
|
