KFH — Antiserum, Positive Control, Blastomyces Dermatitidis Class II

FDA Device Classification

Classification Details

Product Code
KFH
Device Class
Class II
Regulation Number
866.3060
Submission Type
Review Panel
MI
Medical Specialty
Microbiology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K880029immuno-mycologicsEXO-ANTIGEN IDENTIFICATION SYSTEM CAT.# EX1001February 24, 1988
K792681meridian diagnosticsBLASTOMYCES DERMATITIDIS POS/CONTROLJanuary 17, 1980
K792685meridian diagnosticsBLASTOMYCES DERMATITIDIS, ANTISERUMJanuary 17, 1980
K760833i mANTI-BLASTOMYCES CONTROL SERUM (YEAST)November 1, 1976