Creatinine Test System For At Home Prescription Use

SHB · Class II — Moderate Risk (510(k) clearance required) · Clinical Chemistry · 21 CFR 862.1225

Classification

FDA Product Code: SHB
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 862.1225
Review panel: CH
Medical specialty: Clinical Chemistry
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

Definition

For the quantitative measurement of creatinine in home use settings by patients as an aid to monitor kidney function. This device is for prescription use only.

Market data

Cleared 510(k) submissions: 1
Registered establishments: 0

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown