← FDA Medical Device Classifications

Reagent/Device, Inoculum Calibration

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

Classification

FDA Product Code

LIE

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

7

Registered establishments

5

Source

Authoritative

FDA Device Classification database

Machine

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