← FDA Medical Device Classifications

Chamber, Environmental For The Storage Of Platelet Concentrate

KSH · Class II — Moderate Risk (510(k) clearance required) · Hematology · 21 CFR 864.9575

Classification

FDA Product Code

KSH

Device class

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

Regulation

21 CFR 864.9575

Review panel

HE

Medical specialty

Hematology

Submission type

4

GMP exempt

N

Life sustaining

N

Implant

N

Third-party review

N

Market data

Cleared 510(k) submissions

0

Registered establishments

8

Source

Authoritative

FDA Device Classification database

Machine

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