510(k) K000915 ยท MQK Labware, Assisted Reproduction
PASTEUR PIPET - STERILE 9, PASTEUR PIPET - STERILE 5 3/4, MODELS 16-PP-9, 16-PP-5.75
| Applicant | Humagen Fertility Diagnostics, Inc., Charlottesville VA, US |
| Decision | Substantially Equivalent, May 12, 2000 |
| Received | Mar 22, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K000915
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 30, 2014 | ORIGIO, Inc Name: Pasteur Pipets, used by the embryologist in the IVF Laboratory.
Model numbers:
PP-5.75-90
PP-9-90
PP-5.75-90PL
PP-9-90PL Terminated |
MQK | None listed |
| Sep 18, 2007 | Humagen Fertility Diagnostics, Inc. IVF Pasteur Pipettes, glass, cotton plugged, length 9", in boxes of 90 consisting of 30 nylon tube packages of 3 pipettes each. Item # PP-9-90PL. Boxes are labeled in part ***Humagen Fertility Diagno Terminated |
MQK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.