HICHEM PHOSPHORUS REAGENT KIT— 510(k) K981769
Substantially EquivalentElan Pharma, Inc.
FDA 510(k) clearance K981769 for HICHEM PHOSPHORUS REAGENT KIT, Substantially Equivalent on 1998-06-29. Applicant: Elan Pharma, Inc.. Device class: 1.
Clearance details
- Applicant
- Elan Pharma, Inc.
- Product code
- Code CEO
- Device class
- Class 1
- Regulation
- 21 CFR 862.1580
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Brea, CA, US
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