Company ยท US
Irvine Scientific Sales Co., Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1997 to 2017. Name variants (Inc, Corp, punctuation) are merged.
40510(k) clearances (0 in 12 months)
1recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 31, 2017 | K171224 | Arctic Sperm Cryopreservation Medium Irvine Scientific Sales Co., Inc. | MQL |
| Jun 8, 2017 | K170681 | Continuous Single Culture -NX (CSCM-NX) Irvine Scientific Sales Co., Inc. | MQL |
| Jun 7, 2017 | K170602 | Continuous Single Culture-NX Complete (CSCM-NXC) Irvine Scientific Sales Co., Inc. | MQL |
| Jul 19, 2012 | K121572 | CONTINUOUS SINGLE CULTURE COMPLETE Irvine Scientific Sales Co., Inc. | MQL |
| Jun 6, 2012 | K121128 | MULTIPURPOSE HANDLING MEDIUM Irvine Scientific Sales Co., Inc. | MQL |
| Mar 3, 2010 | K093273 | VIT KIT - FREEZE AND THAW Irvine Scientific Sales Co., Inc. | MQL |
| Feb 12, 2008 | K072609 | SINGLE STEP MEDIUM Irvine Scientific Sales Co., Inc. | MQL |
| Jan 30, 2008 | K072608 | LYOPHILIZED MULTIBLAST MEDIUM KIT Irvine Scientific Sales Co., Inc. | MQL |
| Jan 25, 2008 | K072607 | LYOPHILIZED EARLY CLEAVAGE MEDIUM (ECM) KIT Irvine Scientific Sales Co., Inc. | MQL |
| Oct 18, 2006 | K061549 | AMNIOSTAT-FLM-PG Irvine Scientific Sales Co., Inc. | JHG |
| Oct 13, 2006 | K061679 | WALLACE ARTIFICIAL INSEMINATION CATHETER Irvine Scientific Sales Co., Inc. | LKF |
| Apr 24, 2006 | K060168 | VITRIFICATION FREEZE KIT, VITRIFICATION THAW KIT Irvine Scientific Sales Co., Inc. | MQL |
| Aug 9, 2004 | K041562 | CRYOTIP Irvine Scientific Sales Co., Inc. | MQH |
| Apr 26, 2004 | K034063 | MULTIBLAST MEDIUM Irvine Scientific Sales Co., Inc. | MQL |
| Jan 15, 2004 | K033462 | EARLY CLEAVAGE MEDIUM (ECM) Irvine Scientific Sales Co., Inc. | MQL |
| Dec 19, 2003 | K032887 | PHENOL RED STOCK SOLUTION Irvine Scientific Sales Co., Inc. | MQL |
| Nov 4, 2002 | K022931 | HYALURONIDASE SOLUTION Irvine Scientific Sales Co., Inc. | MQL |
| Jul 5, 2002 | K021358 | EMBRYO BIOPSY MEDIUM Irvine Scientific Sales Co., Inc. | MQL |
| Jan 18, 2002 | K013518 | EMBRYO FREEZE MEDIUM, EMBRYO THAW MEDIUM Irvine Scientific Sales Co., Inc. | MQL |
| Jul 18, 2001 | K011938 | OIL FOR EMBRYO CULTURE Irvine Scientific Sales Co., Inc. | MQL |
| Jun 13, 2001 | K011598 | WATER FOR ASSISTED REPRODUCTIVE TECHNOLOGIES (A.R.T.) USE Irvine Scientific Sales Co., Inc. | MTW |
| Jan 17, 2001 | K003278 | COMPLETE HUMAN TUBAL FLUID (HTF) WITH SERUM SUBSTITUTE SUPPLEMENT, MODEL 9922 Irvine Scientific Sales Co., Inc. | MQL |
| Dec 7, 2000 | K003448 | DEXTRAN SERUM SUPPLEMENT (DSS), MODEL 9301 Irvine Scientific Sales Co., Inc. | MQL |
| Mar 13, 2000 | K000309 | BLASTOCYST FREEZE MEDIUM, BLASTOCYST THAW MEDIUM Irvine Scientific Sales Co., Inc. | MQL |
| Dec 6, 1999 | K991339 | TYRODE'S SOLUTION-ACIDIFIED Irvine Scientific Sales Co., Inc. | MQL |
| Sep 14, 1999 | K991419 | 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. | MQL |
| Jul 14, 1999 | K991343 | PVP (POLYVINYLPYRROLIDONE) Irvine Scientific Sales Co., Inc. | MQL |
| Jul 14, 1999 | K991338 | BOVINE SERUM ALBUMIN (BSA) Irvine Scientific Sales Co., Inc. | MQL |
| Jul 8, 1999 | K991342 | PBS 1X- DULBECCO'S PHOSPHATE BUFFERED SALINE SOLUTION Irvine Scientific Sales Co., Inc. | MQL |
| Jul 8, 1999 | K991341 | ISOLATE, ISOLATE CONCENTRATE, ISOLATE STOCK SOLUTION Irvine Scientific Sales Co., Inc. | MQL |
| Jul 8, 1999 | K991337 | SPERM MAINTENANCE MEDIUM WITH GLYCEROL Irvine Scientific Sales Co., Inc. | MQL |
| Jul 2, 1999 | K991421 | FREEZING MEDIUM - TEST YOLK BUFFER (TYB) WITH GLYCEROL, REFRIGERATION MEDIUM - TEST YOLK BUFFER 9TYB) Irvine Scientific Sales Co., Inc. | MQL |
| Jul 2, 1999 | K991420 | MODIFIED HAM'S F-10 WITH ALBUMIN Irvine Scientific Sales Co., Inc. | MQL |
| Apr 26, 1999 | K983588 | SPERM WASHING MEDIUM, MODIFIED SPERM WASHING MEDIUM Irvine Scientific Sales Co., Inc. | MQL |
| Apr 23, 1999 | K983579 | SYNTHETIC SERUM SUBSTITUTE (SSS) Irvine Scientific Sales Co., Inc. | MQL |
| Feb 18, 1999 | K983589 | P-1 (PREIMPLANTATION STAGE ONE) MEDIUM Irvine Scientific Sales Co., Inc. | MQL |
| Feb 18, 1999 | K983586 | HTF MEDIUM, MODIFIED HTF MEDIUM- HEPES, HTF POWDER (WITHOUT ANTIBIOTICS), MODIFIED HTG POWDER- HEPES (WITHOUT ANTIBODITI Irvine Scientific Sales Co., Inc. | MQL |
| Feb 18, 1999 | K983580 | BLASTOCYST MEDIUM Irvine Scientific Sales Co., Inc. | MQL |
| Feb 8, 1999 | K983584 | HUMAN SERUM ALBUMIN (HSA) Irvine Scientific Sales Co., Inc. | MQL |
| Jul 3, 1997 | K971809 | ISOLATE Irvine Scientific Sales Co., Inc. | MQL |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 22, 2008 | Irvine Scientific Sales Co Inc Wallace Oocyte Recovery Needles,Oocyte Recovery sets, 750 mm tube with flushing connector, Product Number: KLN-750, and KLN-750.
Retrieval of Oocytes. Terminated |
MQE | K000628 K012068 |