B-CLONE HCG ASSAY— 510(k) K831155
Substantially EquivalentMonoclonal Antibodies, Inc.
FDA 510(k) clearance K831155 for B-CLONE HCG ASSAY, Substantially Equivalent on 1983-06-02. Applicant: Monoclonal Antibodies, Inc.. Device class: 2.
Clearance details
- Applicant
- Monoclonal Antibodies, Inc.
- Product code
- Code JHJ
- Device class
- Class 2
- Regulation
- 21 CFR 862.1155
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
Recent devices under product code JHJ
view allMore clearances from Monoclonal Antibodies, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.