← FDA Medical Device Classifications

Panels, Test, Susceptibility, Antimicrobial

LTT · Class II — Moderate Risk (510(k) clearance required) · Microbiology · 21 CFR 866.1640

Classification

FDA Product Code

LTT

Device class

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

Regulation

21 CFR 866.1640

Review panel

MI

Medical specialty

Microbiology

Submission type

1

GMP exempt

N

Life sustaining

N

Implant

N

Third-party review

Y

Market data

Cleared 510(k) submissions

50

Registered establishments

13

Source

Authoritative

FDA Device Classification database

Machine

JSON-LD · Markdown