510(k) K892928 ยท JSO Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar
HAEMOPHILUS TEST MEDIUM (AGAR)
| Applicant | Remel Co., Lenexa KS, US |
| Decision | Substantially Equivalent, Jun 13, 1989 |
| Received | Apr 21, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K892928
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 29, 2023 | Remel, Inc Remel Haemophilus Test Medium (Agar) (150mm), 10/pk, REF R04033; and Remel Haemophilus Test Medium (Agar)(100mm), 10/pk, REF 01503. For In Vitro Diagnostic Use. Open, Classified |
JSO | None listed |
| Mar 10, 2021 | Remel Inc Remel Haemophilus Test Medium (150 mm) 10/PK, REF 04033
Remel Haemophilus Test Medium (HTM) is a solid medium recommended for use in qualitative procedures by the Clinical and Laboratory Standards In Open, Classified |
JSO | None listed |
| Mar 10, 2021 | Remel Inc Remel Haemophilus Test Medium(100mm) 10/PK, REF: R01503
Remel Haemophilus Test Medium (HTM) is a solid medium recommended for use in qualitative procedures by the Clinical and Laboratory Standards I Open, Classified |
JSO | None listed |
| Aug 3, 2011 | Remel Inc remel Haemophilus Test Medium (Agar), 100mm plates, 10/pk, Ref. #R01503. The firm name on the label is Remel, Lenexa, KS.
For use in qualitative procedures by the Clinical and Laboratory Standards Terminated |
JSO | None listed |
| Aug 3, 2011 | Remel Inc remel Haemophilus Test Medium (Agar), 150mm plates, 10/pk, Ref. #R04033. The firm name on the label is Remel, Lenexa, KS.
For use in qualitative procedures by the Clinical and Laboratory Standards Terminated |
JSO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.