ULTRAZYME PLUS GAMMA-GT, #64959/65032— 510(k) K823883
Substantially EquivalentEmd Chemicals, Inc.
FDA 510(k) clearance K823883 for ULTRAZYME PLUS GAMMA-GT, #64959/65032, Substantially Equivalent on 1983-01-28. Applicant: Emd Chemicals, Inc.. Device class: 1.
Clearance details
- Applicant
- Emd Chemicals, Inc.
- Product code
- Code JQB
- Device class
- Class 1
- Regulation
- 21 CFR 862.1360
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
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