← FDA Medical Device Classifications

Radioimmunoassay, Androstenedione

CIZ · Class I — Low Risk (general controls) · Clinical Chemistry · 21 CFR 862.1075

Classification

FDA Product Code
CIZ
Device class
Class I — Low Risk (general controls)
Regulation
21 CFR 862.1075
Review panel
CH
Medical specialty
Clinical Chemistry
Submission type
4
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N

Market data

Cleared 510(k) submissions
10
Registered establishments
19

Source

Authoritative
FDA Device Classification database
Machine
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