IMMUNOWELL DSDNA ANTIBODY TEST— 510(k) K914801
Substantially EquivalentGeneral Biometrics, Inc.
FDA 510(k) clearance K914801 for IMMUNOWELL DSDNA ANTIBODY TEST, Substantially Equivalent on 1991-12-09. Applicant: General Biometrics, Inc.. Device class: 2.
Clearance details
- Applicant
- General Biometrics, Inc.
- Product code
- Code DHC
- Device class
- Class 2
- Regulation
- 21 CFR 866.5820
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Diego, CA, US
Recent devices under product code DHC
view allMore clearances from General Biometrics, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.