← FDA Medical Device Classifications

Enzyme Immunoassay, Fetal Fibronectin

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

Classification

FDA Product Code

LKV

Device class

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

Regulation

—

Review panel

CH

Medical specialty

Unknown

Submission type

2

GMP exempt

N

Life sustaining

N

Implant

N

Third-party review

N

Market data

Cleared 510(k) submissions

0

Registered establishments

4

Source

Authoritative

FDA Device Classification database

Machine

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