← FDA Medical Device Classifications

Blood, Occult, Enzymatic Method, In Urine

JIP · Class II — Moderate Risk (510(k) clearance required) · Hematology · 21 CFR 864.6550

Classification

FDA Product Code

JIP

Device class

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

Regulation

21 CFR 864.6550

Review panel

HE

Medical specialty

Hematology

Submission type

1

GMP exempt

N

Life sustaining

N

Implant

N

Third-party review

Y

Market data

Cleared 510(k) submissions

0

Registered establishments

8

Source

Authoritative

FDA Device Classification database

Machine

JSON-LD · Markdown