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Visual, Pregnancy Hcg, Prescription Use

JHI · Class II — Moderate Risk (510(k) clearance required) · Clinical Chemistry · 21 CFR 862.1155

Classification

FDA Product Code

JHI

Device class

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

Regulation

21 CFR 862.1155

Review panel

CH

Medical specialty

Clinical Chemistry

Submission type

1

GMP exempt

N

Life sustaining

N

Implant

N

Third-party review

Y

Market data

Cleared 510(k) submissions

375

Registered establishments

102

Source

Authoritative

FDA Device Classification database

Machine

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