← FDA Medical Device Classifications
Particle-Size Measuring Instrument
REN
· Not classified · Unknown
Classification
FDA Product Code
REN
Device class
Not classified
Regulation
—
Review panel
—
Medical specialty
Unknown
Submission type
—
GMP exempt
Y
Life sustaining
—
Implant
—
Third-party review
—
Definition
Product, laser, instrument, particle size measurement; An instrument or system incorporating a laser for determining the size or number of particles of particles a test sample.
Market data
Cleared 510(k) submissions
0
Registered establishments
0
Source
Authoritative
FDA Device Classification database
Machine
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