Product code GOY— Microbiology

CHANGE IN STERILIZATION PROCEDURE

Classification name: Antisera, Agglutinating, B. Pertussis, All
Device class: Class 1
Regulation: 21 CFR 866.3065
Advisory panel: Microbiology
Total cleared: 1
First cleared: 1978-12-04
Most recent: 1978-12-04

Market context for product code GOY

FDA has cleared 1 device under product code GOY, all in 1978, filed by 1 applicant company. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

Top applicants under product code GOY

Absorbent Cotton Co., Inc.1 clearance

Recent clearances under product code GOY

K781727 — CHANGE IN STERILIZATION PROCEDUREAbsorbent Cotton Co., Inc.·1978-12-04

Data sourced from openFDA. This site is unofficial and independent of the FDA.