← FDA Medical Device Classifications

Kit, Assay, Estrogen Receptor

LPJ · Class III — High Risk (PMA approval required, life-sustaining) · Hematology · 21 CFR 864.1860

Classification

FDA Product Code

LPJ

Device class

Class III — High Risk (PMA approval required, life-sustaining)

Regulation

21 CFR 864.1860

Review panel

CH

Medical specialty

Hematology

Submission type

2

GMP exempt

N

Life sustaining

N

Implant

N

Third-party review

N

Market data

Cleared 510(k) submissions

0

Registered establishments

0

Source

Authoritative

FDA Device Classification database

Machine

JSON-LD · Markdown