LHJ — Staphylococcus Aureus Protein A Insoluble Class I

FDA Device Classification

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

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K940557unipathSTAPHYTECT-ODJuly 28, 1994
K842709immucellIMMUSTAPH LATEX AGGLUTINATION KITAugust 3, 1984
K812181oxoid u.s.aSTAPHYLOCOCCAL PROTEIN A INSOLUBLEAugust 25, 1981