25-OH VITAMIN D ELISA— 510(k) K123660
Substantially EquivalentEuroimmun US
FDA 510(k) clearance K123660 for 25-OH VITAMIN D ELISA, Substantially Equivalent on 2013-07-17. Applicant: Euroimmun US. Device class: 2.
Clearance details
- Applicant
- Euroimmun US
- Product code
- Code MRG
- Device class
- Class 2
- Regulation
- 21 CFR 862.1825
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Morris Plains, NJ, US
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