ULTRAZYME PLUS AMYL #65031&64982— 510(k) K821459
Substantially EquivalentEmd Chemicals, Inc.
FDA 510(k) clearance K821459 for ULTRAZYME PLUS AMYL #65031&64982, Substantially Equivalent on 1982-05-28. Applicant: Emd Chemicals, Inc.. Device class: 2.
Clearance details
- Applicant
- Emd Chemicals, Inc.
- Product code
- Code JFJ
- Device class
- Class 2
- Regulation
- 21 CFR 862.1070
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
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