510(k) K100596 ยท MQK Labware, Assisted Reproduction
CRYOPETTE
| Applicant | Mid-Atlantic Diagnostics, Inc., Sandy Spring MD, US |
| Decision | Substantially Equivalent, Dec 6, 2010 |
| Received | Mar 2, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K100596
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 23, 2012 | ORIGIO HUMAGEN PIPETS INC. ORIGIO MIDATLANTIC DEVICES CRYOPETTE (r) Rx only Single use only CRY-PETTE-CL LOT 123456 2013-10-10 Exp. date *** MADE IN THE USA STERILE R ***Origio, Inc. 3400 Hunter's Way, Charlottesville, VA 2291 Terminated |
MQK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.