510(k) K850291 ยท JTZ Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth
MUELLER HINTON AGAR W/4% NACL W/ANTIBIOTICS
| Applicant | Remel Co., Lenexa KS, US |
| Decision | Substantially Equivalent, May 10, 1985 |
| Received | Jan 24, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K850291
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 4, 2018 | Thermo Fisher remel SUPERPACK CS/ 500 SEG/FLASK, REF R01626, Qty:50, plate label: REMEL MH W/OXACILLIN
Product Usage:
Recommended for the use in qualitative procedures to screen Staphylococcus aureus for resistanc Terminated |
JTZ | None listed |
| Jan 15, 2010 | Remel, Inc remel Mueller Hinton Agar w/4% NaCl w/6 mcg/ml Oxacillin, Ref R01626, 10/box. The firm name on the label is Remel, Lenexa, KS.
The product is a solid medium recommended for use in qualitative proced Terminated |
JTZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.