510(k) K043545 ยท LRG Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems
MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS WITH DAPTOMYCIN (0.03 - 16 MCG/ML)
| Applicant | Dade Behring, Inc., West Sacramento CA, US |
| Decision | Substantially Equivalent, Feb 17, 2005 |
| Received | Dec 23, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K043545
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 2, 2020 | Beckman Coulter Inc. MicroScan Pos MIC Panel Type 34 - Product Usage: For the determination of antimicrobial agent susceptibility and/or identification to the species level of rapidly growing aerobic and facultative gram- Terminated |
LRG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.