LHJ — Staphylococcus Aureus Protein A Insoluble Class I
FDA product code LHJ covers "Staphylococcus Aureus Protein A Insoluble", a Class I medical device regulated under 21 CFR 866.3700. Submissions are reviewed by the Microbiology panel. At least 3 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- LHJ
- Device Class
- Class I
- Regulation Number
- 866.3700
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No