Remel, L.P.
Medical device manufacturer in Lenexa, KS.
10510(k) clearances
0PMA approvals
0recalls
Device types
- JTN Susceptibility Test Discs, Antimicrobial 3
- JTY Culture Media, For Isolation Of Pathogenic… 1
- JTZ Culture Media, Antimicrobial Susceptibility… 1
- GMQ Antigens, Nontreponemal, All 1
- GMP Antisera, Control For Nontreponemal Tests 1
- JSM Culture Media, Non-Propagating Transport 1
- JWX Kit, Screening, Staphylococcus Aureus 1
- JSO Culture Media, Antimicrobial Susceptibility… 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K972359 | Remel Bile Esculin Azide Agar W/6 Mcg/Ml VancomycinJSO · Traditional | 08/28/1997SE |
| K964315 | Remel Staph Latex KitJWX · Traditional | 02/07/1997SE |
| K964421 | Remel Meropenem 10UG Susceptibility DiskJTN · Traditional | 12/06/1996SE |
| K961046 | 10B Arginine BrothJSM · Traditional | 09/18/1996SE |
| K955143 | RPR Liquid ControlsGMP · Traditional | 07/30/1996SE |
| K955136 | RPR Card Test KitGMQ · Traditional | 07/29/1996SE |
| K961819 | Streptomycin Disk (300MCG)JTN · Traditional | 07/10/1996SE |
| K961818 | Gentamicin Disk (120MCG)JTN · Traditional | 07/10/1996SE |
| K960313 | Mueller Hinton Agar with 2% NaciJTZ · Traditional | 03/25/1996SE |
| K954986 | GC Base W/ 1% GchiJTY · Traditional | 02/16/1996SE |