VITAMIN B12/FOLATE DUAL RADIOASSAY KITS— 510(k) K812979
Substantially EquivalentAmersham Corp.
FDA 510(k) clearance K812979 for VITAMIN B12/FOLATE DUAL RADIOASSAY KITS, Substantially Equivalent on 1981-11-24. Applicant: Amersham Corp.. Device class: 2.
Clearance details
- Applicant
- Amersham Corp.
- Product code
- Code CGN
- Device class
- Class 2
- Regulation
- 21 CFR 862.1295
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
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