PLATELIA RUBELLA IGG KIT— 510(k) K894946
Substantially EquivalentKallestad Diag, A Div. of Erbamont, Inc.
FDA 510(k) clearance K894946 for PLATELIA RUBELLA IGG KIT, Substantially Equivalent on 1989-12-21. Applicant: Kallestad Diag, A Div. of Erbamont, Inc.. Device class: 2.
Clearance details
- Applicant
- Kallestad Diag, A Div. of Erbamont, Inc.
- Product code
- Code LFX
- Device class
- Class 2
- Regulation
- 21 CFR 866.3510
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Chaska, MN, US
Recent devices under product code LFX
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