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Bioptigen, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
4
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K162783EnFocus 2300, EnFocus 4400December 9, 2016
K150722EnFocus 2300, EnFocus 4400December 2, 2015
K120057ENVISU SPECTRAL DOMAIN OPHTHALMIC IMAGING SYSTEM (SDOIS)May 11, 2012
K063343BIOPTIGEN SPECTRAL DOMAIN OPHTHALMIC IMAGING SYSTEMDecember 13, 2006