Data / Medical devices / United States / Irvine Scientific LLC
Irvine Scientific LLC: FDA-registered device maker in Santa Ana, CA, United States, 20 510(k) clearances
Irvine Scientific LLC is registered with the FDA (registration 3036495174) in Santa Ana, CA, United States. It lists 4 device types. The FDA files 20 510(k) clearances under its listings, the newest dated September 12, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3036495174
- Address
- 1830 E Warner Ave, Santa Ana, CA, United States, 92705
- Owner or operator
- IRVINE SCIENTIFIC LLC (10092955)
- Roles
- Complaint file establishment, Repackager or relabeler, Specification developer
- First device listed
- March 10, 2025
- Registered through
- 2026
- Brand names listed
- 10% Polyvinylpyrrolidone (PVP) Solution with Human Serum Albumin (HSA), 7% Polyvinylpyrrolidone (PVP) Solution with Human Serum Albumin (HSA), Arctic Sperm Cryopreservation Medium, Chang Amnio; Chang Marrow (with gentamicin); Chang Medium B; Chang Medium BMC, Chang Medium B Chang Medium MF Chang Medium C Kit (lyophilized), Chang Medium BMC Chang Amnio Chang Marrow (with gentamicin) Chang Medium In Situ, Chang Medium C Kit (Lyophilized with Gentamicin) Colcemid Solution Chang Medium D Chang Medium C, Chang Medium C; Chang Medium C Kit (Lyophilized with Gentamicin); Chang Medium C Kit (lyophilized) and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Kit, Culture, Chromosome | KIQ | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Labware, Assisted Reproduction | MQK | 2 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Media And Components, Synthetic Cell And Tissue Culture | KIT | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Media, Reproductive | MQL | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 12, 2025 | K250445 | Fast Warm - NX | MQL | Substantially Equivalent | Fujifilm Irvine Scientific | accessdata.fda.gov |
| September 26, 2024 | K241341 | cryo-GO Vitrification Device | MQK | Substantially Equivalent | Fujifilm Irvine Scientific | accessdata.fda.gov |
| April 24, 2024 | K233764 | SSS-NX (Serum Substitute Supplement-NX) | MQL | Substantially Equivalent | Fujifilm Irvine Scientific | accessdata.fda.gov |
| June 21, 2019 | K190152 | Vit Kit- Freeze NX and Vit Kit- Warm NX | MQL | Substantially Equivalent | Fujifilm Irvine Scientific, Inc. | accessdata.fda.gov |
| August 31, 2017 | K171224 | Arctic Sperm Cryopreservation Medium | MQL | Substantially Equivalent | Irvine Scientific Sales Co., Inc. | accessdata.fda.gov |
| June 8, 2017 | K170681 | Continuous Single Culture -NX (CSCM-NX) | MQL | Substantially Equivalent | Irvine Scientific Sales Co., Inc. | accessdata.fda.gov |
| June 7, 2017 | K170602 | Continuous Single Culture-NX Complete (CSCM-NXC) | MQL | Substantially Equivalent | Irvine Scientific Sales Co., Inc. | accessdata.fda.gov |
| May 4, 2016 | K160006 | Vit Kit-Freeze Oocytes, Embryos and PN zygotes Vitrification Freeze Kit, Vit Kit-Thaw Oocytes, Embryos and PN zygotes Vitrification Thaw Kit | MQL | Substantially Equivalent | Irvine Scientific | accessdata.fda.gov |
| July 19, 2012 | K121572 | CONTINUOUS SINGLE CULTURE COMPLETE | MQL | Substantially Equivalent | Irvine Scientific Sales Co., Inc. | accessdata.fda.gov |
| June 6, 2012 | K121128 | MULTIPURPOSE HANDLING MEDIUM | MQL | Substantially Equivalent | Irvine Scientific Sales Co., Inc. | accessdata.fda.gov |
| February 12, 2008 | K072609 | SINGLE STEP MEDIUM | MQL | Substantially Equivalent | Irvine Scientific Sales Co., Inc. | accessdata.fda.gov |
| November 4, 2002 | K022931 | HYALURONIDASE SOLUTION | MQL | Substantially Equivalent | Irvine Scientific Sales Co., Inc. | accessdata.fda.gov |
| July 18, 2001 | K011938 | OIL FOR EMBRYO CULTURE | MQL | Substantially Equivalent | Irvine Scientific Sales Co., Inc. | accessdata.fda.gov |
| July 14, 1999 | K991343 | PVP (POLYVINYLPYRROLIDONE) | MQL | Substantially Equivalent | Irvine Scientific Sales Co., Inc. | accessdata.fda.gov |
| July 8, 1999 | K991342 | PBS 1X- DULBECCO'S PHOSPHATE BUFFERED SALINE SOLUTION | MQL | Substantially Equivalent | Irvine Scientific Sales Co., Inc. | accessdata.fda.gov |
| July 8, 1999 | K991341 | ISOLATE, ISOLATE CONCENTRATE, ISOLATE STOCK SOLUTION | MQL | Substantially Equivalent | Irvine Scientific Sales Co., Inc. | accessdata.fda.gov |
| July 2, 1999 | K991421 | FREEZING MEDIUM - TEST YOLK BUFFER (TYB) WITH GLYCEROL, REFRIGERATION MEDIUM - TEST YOLK BUFFER 9TYB) | MQL | Substantially Equivalent | Irvine Scientific Sales Co., Inc. | accessdata.fda.gov |
| April 26, 1999 | K983588 | SPERM WASHING MEDIUM, MODIFIED SPERM WASHING MEDIUM | MQL | Substantially Equivalent | Irvine Scientific Sales Co., Inc. | accessdata.fda.gov |
| February 18, 1999 | K983586 | HTF MEDIUM, MODIFIED HTF MEDIUM- HEPES, HTF POWDER (WITHOUT ANTIBIOTICS), MODIFIED HTG POWDER- HEPES (WITHOUT ANTIBODITI | MQL | Substantially Equivalent | Irvine Scientific Sales Co., Inc. | accessdata.fda.gov |
| February 8, 1999 | K983584 | HUMAN SERUM ALBUMIN (HSA) | MQL | Substantially Equivalent | Irvine Scientific Sales Co., Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Media, Reproductive
- All makers of Labware, Assisted Reproduction
- All makers of Kit, Culture, Chromosome
- All makers of Media And Components, Synthetic Cell And Tissue Culture
Updated September 12, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.