510(k) K980135 ยท JJS Controls For Blood-Gases, (Assayed And Unassayed)
QUALICHECK5+ MODELS S7730, S7740, S7750, S7760
| Applicant | Radiometer America, Inc., Westlake OH, US |
| Decision | Substantially Equivalent, Jan 28, 1998 |
| Received | Jan 15, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K980135
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 7, 2017 | Radiometer America Inc AutoCheck5+, Level 2, specifically designed for Radiometer Americas blood gas analyzers
The QUALICHECK+ quality control (QC) ampoules are specifically designed for Radiometer America s blood gas anal Terminated |
JJS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.