← FDA Medical Device Classifications

Test, Time, Prothrombin

GJS · Class II — Moderate Risk (510(k) clearance required) · Hematology · 21 CFR 864.7750

Classification

FDA Product Code

GJS

Device class

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

Regulation

21 CFR 864.7750

Review panel

HE

Medical specialty

Hematology

Submission type

1

GMP exempt

N

Life sustaining

N

Implant

N

Third-party review

N

Market data

Cleared 510(k) submissions

127

Registered establishments

31

Source

Authoritative

FDA Device Classification database

Machine

JSON-LD · Markdown