ENZYMATIC CHOLESTERAL OXIDASE #650550— 510(k) K821441
Substantially EquivalentEmd Chemicals, Inc.
FDA 510(k) clearance K821441 for ENZYMATIC CHOLESTERAL OXIDASE #650550, Substantially Equivalent on 1982-06-01. Applicant: Emd Chemicals, Inc.. Device class: 1.
Clearance details
- Applicant
- Emd Chemicals, Inc.
- Product code
- Code CHH
- Device class
- Class 1
- Regulation
- 21 CFR 862.1175
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
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