HISTOPLASMA CAPSULATUM, ANTISERUM— 510(k) K792718
Substantially EquivalentMeridian Diagnostics, Inc.
FDA 510(k) clearance K792718 for HISTOPLASMA CAPSULATUM, ANTISERUM, Substantially Equivalent on 1980-01-17. Applicant: Meridian Diagnostics, Inc.. Device class: 2.
Clearance details
- Applicant
- Meridian Diagnostics, Inc.
- Product code
- Code GMK
- Device class
- Class 2
- Regulation
- 21 CFR 866.3320
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
Recent devices under product code GMK
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