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System, Fibrinogen Determination

KQJ · Class II — Moderate Risk (510(k) clearance required) · Hematology · 21 CFR 864.7340

Classification

FDA Product Code

KQJ

Device class

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

Regulation

21 CFR 864.7340

Review panel

HE

Medical specialty

Hematology

Submission type

1

GMP exempt

N

Life sustaining

N

Implant

N

Third-party review

Y

Market data

Cleared 510(k) submissions

28

Registered establishments

10

Source

Authoritative

FDA Device Classification database

Machine

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