510(k) K013371 ยท JJQ Colorimeter, Photometer, Spectrophotometer For Clinical Use
UBIT-IR300 INFRARED SPECTROMETRY SYSTEM
| Applicant | Otsuka Pharmaceutical Co., Ltd., North Attleboro MA, US |
| Decision | Substantially Equivalent, Dec 21, 2001 |
| Received | Oct 11, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K013371
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 1, 2008 | Otsuka America Pharmaceutical, Inc. UBiT-IR300 Infrared Spectrophotometer, Software Versions 7.0, 7.01 and 7.11. Terminated |
JJQ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.