← FDA Medical Device Classifications

System, Test, Automated, Antimicrobial Susceptibility, Short Incubation

LON · Class II — Moderate Risk (510(k) clearance required) · Microbiology · 21 CFR 866.1645

Classification

FDA Product Code

LON

Device class

Class II — Moderate Risk (510(k) clearance required)

Regulation

21 CFR 866.1645

Review panel

MI

Medical specialty

Microbiology

Submission type

1

GMP exempt

N

Life sustaining

N

Implant

N

Third-party review

N

Market data

Cleared 510(k) submissions

289

Registered establishments

23

Source

Authoritative

FDA Device Classification database

Machine

JSON-LD · Markdown