ULTRAZYME PLUS LDH, #64950,65038&65039— 510(k) K821466
Substantially EquivalentEmd Chemicals, Inc.
FDA 510(k) clearance K821466 for ULTRAZYME PLUS LDH, #64950,65038&65039, Substantially Equivalent on 1982-06-01. Applicant: Emd Chemicals, Inc.. Device class: 2.
Clearance details
- Applicant
- Emd Chemicals, Inc.
- Product code
- Code CFJ
- Device class
- Class 2
- Regulation
- 21 CFR 862.1440
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
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