Irvine Scientific LLC
Santa Ana, CA, US
IRVINE SCIENTIFIC LLC appears in FDA device records in Santa Ana, CA. FDA records list 16 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 16 510(k) clearances for Irvine Scientific LLC between 1982 and 2016. The busiest year on record is 1987, with 5. The most recent is 2016, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1982 | 4 |
| 1985 | 1 |
| 1987 | 5 |
| 1988 | 1 |
| 1989 | 2 |
| 1990 | 1 |
| 1994 | 1 |
| 2016 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| 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 | |
| K914541 | SPERM MAINTENANCE MEDIUM WITH GLYCEROL | MFD | Substantially Equivalent | |
| K900316 | MODIFIED HAM'S F-10 MEDIUM AND MEDIUM-HEPES | HDR | Substantially Equivalent | |
| K894432 | MODIFIED HAM'S F-10 W/ALBUMIN | HDR | Substantially Equivalent | |
| K894405 | HTF WITH ALBUMIN (CATALOG NO. 9994) | HDR | Substantially Equivalent | |
| K874668 | SPERM WASHING MEDIUM #9983 & MODIFIED #9984 | HDR | Substantially Equivalent | |
| K872203 | CAT. #9972 REFRIGERATION MEDIUM (TEST YOLK BUFFER) | HDR | Substantially Equivalent | |
| K872088 | FREEZING MEDIUM (TEST YOLK BUFFER W/GLYCEROL) | HDR | Substantially Equivalent | |
| K872102 | SPERM WASHING MEDIUM #9932 | HDR | Substantially Equivalent | |
| K871577 | HTF MEDIUM AND MODIFIED HTF MEDIUM-HEPES | HDR | Substantially Equivalent | |
| K861188 | SPERM CAPACITATION MEDIUM | HDR | Substantially Equivalent | |
| K851820 | SPINAL FLUID CONTROL | JJY | Substantially Equivalent | |
| K821560 | LEVEL II LIPID CONTROL | JJY | Substantially Equivalent | |
| K821559 | LEVEL I LIPID CONTROL | JJY | Substantially Equivalent | |
| K821557 | LEVEL I CONTROL SERUM | JJY | Substantially Equivalent | |
| K821558 | LEVEL II CONTROL SERUM | JJX | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3036495174 | 3036495174 | IRVINE SCIENTIFIC LLC | 1830 E Warner Ave, Santa Ana, CA 92705 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- MFDCannula, Intrauterine Insemination
- HDRCap, Cervical
- KIQKit, Culture, Chromosome
- MQKLabware, Assisted Reproduction
- KITMedia And Components, Synthetic Cell And Tissue Culture
- MQLMedia, Reproductive
- JJYMulti-Analyte Controls, All Kinds (Assayed)
- JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
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Data as of , FDA export datePage updated Source: openFDA, public domain