DeviceClearance

Product code FRC— General Hospital

3M Attest Rapid Readout Biological Indicator

Classification name
Indicator, Biological Sterilization Process
Device class
Class 2
Regulation
21 CFR 880.2800
Advisory panel
General Hospital
Total cleared
206
First cleared
Most recent

Market context for product code FRC

FDA has cleared 206 devices under product code FRC between 1977 and 2026, filed by 56 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

last 15 years

Top applicants under product code FRC

Recent clearances under product code FRC

1–100 of 206

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