510(k) K062927 ยท LRG Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems
MICROSCAN MICROSTREP PLUS PANEL AMPICILLIN (0.013 - 16 MCG/ML)
| Applicant | Dade Behring, Inc., West Sacramento CA, US |
| Decision | Substantially Equivalent, Oct 12, 2006 |
| Received | Sep 28, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K062927
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 7, 2015 | Beckman Coulter Inc. MICroSTREP plus 1 Panel, Part No. B1027-201
Product Usage:
MicroScan MICroSTREP plus panels are designed for use in determining quantitative and/or qualitative antimicrobial agent susceptibility of c Terminated |
LTT | None listed |
| Oct 7, 2015 | Beckman Coulter Inc. MICroSTREP plus 2 Panel, Part No. B1027-202
Product Usage:
MicroScan MICroSTREP plus panels are designed for use in determining quantitative and/or qualitative antimicrobial agent susceptibility of c Terminated |
LTT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.