B12/FOLATE SING. TUBE DUAL RADIOASSAY KT— 510(k) K760946
Substantially EquivalentSchwarz Mann
FDA 510(k) clearance K760946 for B12/FOLATE SING. TUBE DUAL RADIOASSAY KT, Substantially Equivalent on 1976-12-21. Applicant: Schwarz Mann. Device class: 2.
Clearance details
- Applicant
- Schwarz Mann
- Product code
- Code CDD
- Device class
- Class 2
- Regulation
- 21 CFR 862.1810
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.