510(k) K153417 ยท JIT Calibrator, Secondary
ST AIA-PACK PROG III Calibrator Set
| Applicant | Tosoh Bioscience, Inc., South San Franciso CA, US |
| Decision | Substantially Equivalent, Dec 18, 2015 |
| Received | Nov 25, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K153417
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 25, 2016 | Tosoh Bioscience, Inc. Instructions for Use (IFU) for Progesterone 3 Calibrator Set, repackaged as one set/package.
The Instructions for Use (IFU) included in the package was for the incorrect lot number. Only the IFU re Terminated |
JIT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.