Product code IBG— Pathology

SPUTASOL

Classification name: Trypsin
Device class: Class 1
Regulation: 21 CFR 864.4400
Advisory panel: Pathology
Total cleared: 2
First cleared: 1977-11-22
Most recent: 1980-11-12

Market context for product code IBG

FDA has cleared 2 devices under product code IBG between 1977 and 1980, filed by 2 applicant companies. 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.

Clearances per year

19801 clearance
19771 clearance

Top applicants under product code IBG

Oxoid U.S.A., Inc.1 clearance
Flow Laboratories, Inc.1 clearance

Recent clearances under product code IBG

K802493 — SPUTASOLOxoid U.S.A., Inc.·1980-11-12
K771955 — TRYPSIN 1%Flow Laboratories, Inc.·1977-11-22

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