REMEL MEROPENEM 10UG SUSCEPTIBILITY DISK— 510(k) K964421
Substantially EquivalentRemel, L.P.
FDA 510(k) clearance K964421 for REMEL MEROPENEM 10UG SUSCEPTIBILITY DISK, Substantially Equivalent on 1996-12-06. Applicant: Remel, L.P.. Device class: 2.
Clearance details
- Applicant
- Remel, L.P.
- Product code
- Code JTN
- Device class
- Class 2
- Regulation
- 21 CFR 866.1620
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Lenexa, KS, US
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