Data / Medical devices / United States / Vitrolife Inc.
Vitrolife Inc.: FDA-registered device maker in San Diego, CA, United States, 6 510(k) clearances
Vitrolife Inc. is registered with the FDA (registration 2031824) in San Diego, CA, United States. It lists 4 device types. The FDA files 6 510(k) clearances under its listings, the newest dated March 20, 2003. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2031824
- FEI number
- 3002757762
- Address
- 4940 Carroll Canyon Rd Ste 100, San Diego, CA, United States, 92121
- Owner or operator
- VITROLIFE AB (9037178)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- November 18, 2010
- Registered through
- 2026
- Brand names listed
- Biopsy Pipette, ENHANCE SPERM FREEZE, ENHANCE-S PLUS HTF CELL ISOLATION MEDIUM, Enhance S-Plus Cell Isolation Medium, Enhance Sperm Wash with & without Gentamicin, Handling Pipette, Hatching Pipette, Holding Pipette and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Hemocytometer | GHO | 1 | Manufacturer | accessdata.fda.gov |
| Media, Reproductive | MQL | 2 | Manufacturer | accessdata.fda.gov |
| Microtools, Assisted Reproduction (Pipettes), Exempt | PUC | 2 | Contract manufacturer | accessdata.fda.gov |
| Radioimmunoassay, Luteinizing Hormone | CEP | 1 | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| March 20, 2003 | K030117 | ENHANCE SPERM FREEZE | MQL | Substantially Equivalent | Conception Technology, Inc. | accessdata.fda.gov |
| February 12, 2003 | K030116 | ENHANCE-S PLUS H | MQL | Substantially Equivalent | Conception Technology, Inc. | accessdata.fda.gov |
| December 13, 2002 | K023717 | SPERM WASH MEDIUM WITH GENTAMICIN | MQL | Substantially Equivalent | Conception Technologies | accessdata.fda.gov |
| December 13, 2002 | K023655 | ENHANCE HTF MEDIUM WITH HEPES | MQL | Substantially Equivalent | Conception Technologies | accessdata.fda.gov |
| July 26, 1999 | K991322 | ENHANCE-S PLUS | MQL | Substantially Equivalent | Conception Technology, Inc. | accessdata.fda.gov |
| July 27, 1987 | K871726 | OVUQUICK SELF-TEST (OVUQUICK; RAMP LH ASSAY) | CEP | Substantially Equivalent | Monoclonal Antibodies, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| December 22, 2014 | 70131 | Class II | Terminated | SpermMar Test 0.7ml Beads Particles Label on bottle: SpermMar Test IgA 0.7ml Beads/Particles-50 Tests IND REF SPMA_S LOT Expiration DO NOT FREEZE/NE PAS CONGELER FertiPro N.V. Label on box: SpermMar Test IGA 50 Determina | The firm is recalling three batches (FP14A09, FP14A10, FP14A11) of SpermMAR IgA test due to new formulation causing the motility of sperm cells to reduce in certain samples when the new bead solution was added. | accessdata.fda.gov |
Compare with other makers
- All makers of Microtools, Assisted Reproduction (Pipettes), Exempt
- All makers of Media, Reproductive
- All makers of Radioimmunoassay, Luteinizing Hormone
- All makers of Hemocytometer
Updated April 15, 2015. 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.