NA ALPHA 1 MICROGLOBULIN KIT— 510(k) K904254
Substantially EquivalentBehring Diagnostics, Inc.
FDA 510(k) clearance K904254 for NA ALPHA 1 MICROGLOBULIN KIT, Substantially Equivalent on 1991-04-05. Applicant: Behring Diagnostics, Inc.. Device class: 2.
Clearance details
- Applicant
- Behring Diagnostics, Inc.
- Product code
- Code JZG
- Device class
- Class 2
- Regulation
- 21 CFR 866.5630
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Somerville, NJ, US
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