Data / Medical devices / United States / Invitrocare Inc
Invitrocare Inc: FDA-registered device maker in Frederick, MD, United States, 11 510(k) clearances
Invitrocare Inc is registered with the FDA (registration 3004882774) in Frederick, MD, United States. It lists 1 device type. The FDA files 11 510(k) clearances under its listings, the newest dated March 23, 2006. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3004882774
- Address
- 8415 Progress Dr Unit F, Frederick, MD, United States, 21701
- Owner or operator
- INVITROCARE INC (10037654)
- Roles
- Manufacturer, Repackager or relabeler
- First device listed
- August 4, 2011
- Registered through
- 2026
- Brand names listed
- HTF (Assisted Reproductive Media, HTF-HEPES, HYALURONIDASE Reagent, Human Serum Albumin (HSA), ISOCARE ONE-STEP, IVC-ONE Medium (embryo culture medium), IVC-THREE Blastocyst Medium, IVC-TWO Medium (embryo culture medium) and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Media, Reproductive | MQL | 2 | Manufacturer, Repackager or relabeler | 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 23, 2006 | K053494 | OIL FOR TISSUE CULTURE, GRADIENT SYSTEM AND SPERMFREEZE | MQL | Substantially Equivalent | Fertipro NV | accessdata.fda.gov |
| December 26, 2002 | K023222 | ISOCARE ONE STEP SPERM PROCESSING MEDIUM CAT# 2207-12 | MQL | Substantially Equivalent | Invitrocare, Inc. | accessdata.fda.gov |
| January 17, 2001 | K003751 | HYALURONIDASE REAGENT, MODEL CAT#2212 | MQL | Substantially Equivalent | Invitrocare, Inc. | accessdata.fda.gov |
| August 14, 2000 | K001967 | PVP-POLYVINYLPYRROLIDONE REAGENT, MODEL CAT#2210 | MQL | Substantially Equivalent | Invitrocare, Inc. | accessdata.fda.gov |
| June 13, 2000 | K001113 | IVC THREE BLASTOCYST MEDIUM, CAT # 2007 | MQL | Substantially Equivalent | Invitrocare, Inc. | accessdata.fda.gov |
| June 8, 2000 | K000989 | SPERM WASH MEDIUM, CAT# 2003/2005 | MQL | Substantially Equivalent | Invitrocare, Inc. | accessdata.fda.gov |
| May 25, 2000 | K993484 | Q-HTF, CAT# 2001 | MQL | Substantially Equivalent | Invitrocare, Inc. | accessdata.fda.gov |
| May 25, 2000 | K000938 | IVC ONE MEDIUM | MQL | Substantially Equivalent | Invitrocare, Inc. | accessdata.fda.gov |
| May 25, 2000 | K000937 | IVC TWO MEDIUM | MQL | Substantially Equivalent | Invitrocare, Inc. | accessdata.fda.gov |
| May 4, 2000 | K000940 | HUMAN SERUM ALBUMIN (HSA) | MQL | Substantially Equivalent | Invitrocare, Inc. | accessdata.fda.gov |
| May 4, 2000 | K000939 | HTF-HEPES | MQL | Substantially Equivalent | Invitrocare, Inc. | accessdata.fda.gov |
Compare with other makers
Updated March 23, 2006. 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.