← FDA Medical Device Classifications

Test, Leukocyte Peroxidase

GIA · Class I — Low Risk (general controls) · Hematology · 21 CFR 864.7675

Classification

FDA Product Code

GIA

Device class

Class I — Low Risk (general controls)

Regulation

21 CFR 864.7675

Review panel

PA

Medical specialty

Hematology

Submission type

4

GMP exempt

N

Life sustaining

N

Implant

N

Third-party review

N

Market data

Cleared 510(k) submissions

3

Registered establishments

4

Source

Authoritative

FDA Device Classification database

Machine

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