← FDA Medical Device Classifications

Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine

KLI · Class II — Moderate Risk (510(k) clearance required) · Clinical Chemistry · 21 CFR 862.1700

Classification

FDA Product Code

KLI

Device class

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

Regulation

21 CFR 862.1700

Review panel

CH

Medical specialty

Clinical Chemistry

Submission type

4

GMP exempt

N

Life sustaining

N

Implant

N

Third-party review

N

Market data

Cleared 510(k) submissions

86

Registered establishments

45

Source

Authoritative

FDA Device Classification database

Machine

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