PARAMAX TRIGLYCERID REAGENT— 510(k) K964346
Substantially EquivalentDade Intl., Inc.
FDA 510(k) clearance K964346 for PARAMAX TRIGLYCERID REAGENT, Substantially Equivalent on 1997-03-28. Applicant: Dade Intl., Inc.. Device class: 1.
Clearance details
- Applicant
- Dade Intl., Inc.
- Product code
- Code CDT
- Device class
- Class 1
- Regulation
- 21 CFR 862.1705
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Miami, FL, US
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