GOY — Antisera, Agglutinating, B. Pertussis, All Class I

FDA Device Classification

FDA product code GOY covers "Antisera, Agglutinating, B. Pertussis, All", a Class I medical device regulated under 21 CFR 866.3065. Submissions are reviewed by the Microbiology panel. At least 1 recent 510(k) clearance has been granted under this product code.

Classification Details

Product Code
GOY
Device Class
Class I
Regulation Number
866.3065
Submission Type
Review Panel
MI
Medical Specialty
Microbiology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K781727absorbent cotton coCHANGE IN STERILIZATION PROCEDUREDecember 4, 1978