FDA 510(k) Applications Submitted by ROBERTA L JOHNSON
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K000309 |
02/01/2000 |
BLASTOCYST FREEZE MEDIUM, BLASTOCYST THAW MEDIUM |
IRVINE SCIENTIFIC SALES CO., INC. |
| K991337 |
04/19/1999 |
SPERM MAINTENANCE MEDIUM WITH GLYCEROL |
IRVINE SCIENTIFIC SALES CO., INC. |
| K991338 |
04/19/1999 |
BOVINE SERUM ALBUMIN (BSA) |
IRVINE SCIENTIFIC SALES CO., INC. |
| K991339 |
04/19/1999 |
TYRODE'S SOLUTION-ACIDIFIED |
IRVINE SCIENTIFIC SALES CO., INC. |
| K991341 |
04/19/1999 |
ISOLATE, ISOLATE CONCENTRATE, ISOLATE STOCK SOLUTION |
IRVINE SCIENTIFIC SALES CO., INC. |
| K991342 |
04/19/1999 |
PBS 1X- DULBECCO'S PHOSPHATE BUFFERED SALINE SOLUTION |
IRVINE SCIENTIFIC SALES CO., INC. |
| K991343 |
04/19/1999 |
PVP (POLYVINYLPYRROLIDONE) |
IRVINE SCIENTIFIC SALES CO., INC. |
| K991419 |
04/23/1999 |
MODIFIED HAM'S F-10 BASAL MEDIUM, MODIFIED HAMS'S F-10 BASAL MEDIUM HEPES, MODIFIED HAM'S F-10 SUPPLEMENT (50X) IYOPHILI |
IRVINE SCIENTIFIC SALES CO., INC. |
| K991420 |
04/23/1999 |
MODIFIED HAM'S F-10 WITH ALBUMIN |
IRVINE SCIENTIFIC SALES CO., INC. |
| K991421 |
04/23/1999 |
FREEZING MEDIUM - TEST YOLK BUFFER (TYB) WITH GLYCEROL, REFRIGERATION MEDIUM - TEST YOLK BUFFER 9TYB) |
IRVINE SCIENTIFIC SALES CO., INC. |
| K983579 |
10/13/1998 |
SYNTHETIC SERUM SUBSTITUTE (SSS) |
IRVINE SCIENTIFIC SALES CO., INC. |
| K983580 |
10/13/1998 |
BLASTOCYST MEDIUM |
IRVINE SCIENTIFIC SALES CO., INC. |
| K983584 |
10/13/1998 |
HUMAN SERUM ALBUMIN (HSA) |
IRVINE SCIENTIFIC SALES CO., INC. |
| K983586 |
10/13/1998 |
HTF MEDIUM, MODIFIED HTF MEDIUM- HEPES, HTF POWDER (WITHOUT ANTIBIOTICS), MODIFIED HTG POWDER- HEPES (WITHOUT ANTIBODITI |
IRVINE SCIENTIFIC SALES CO., INC. |
| K983588 |
10/13/1998 |
SPERM WASHING MEDIUM, MODIFIED SPERM WASHING MEDIUM |
IRVINE SCIENTIFIC SALES CO., INC. |
| K983589 |
10/13/1998 |
P-1 (PREIMPLANTATION STAGE ONE) MEDIUM |
IRVINE SCIENTIFIC SALES CO., INC. |
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