DIRECTACLONE CG SLIDE PREGNANCY TEST— 510(k) K860945
Substantially EquivalentPacific Biotech, Inc.
FDA 510(k) clearance K860945 for DIRECTACLONE CG SLIDE PREGNANCY TEST, Substantially Equivalent on 1986-05-02. Applicant: Pacific Biotech, Inc.. Device class: 2.
Clearance details
- Applicant
- Pacific Biotech, 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
- San Diego, CA, US
Recent devices under product code JHJ
view allMore clearances from Pacific Biotech, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.