Bioptigen, Inc. is one of 25969 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Bioptigen, Inc. - FDA 510(k) Cleared Devices
Recent clearances: EnFocus 2300, EnFocus 4400, EnFocus 2300, EnFocus 4400, ENVISU SPECTRAL DOMAIN OPHTHALMIC IMAGING SYSTEM (SDOIS)
4
Total
4
Cleared
0
Denied
Bioptigen, Inc. has 4 FDA 510(k) cleared medical devices. Based in Washington, US.
Historical record: 4 cleared submissions from 2006 to 2016. Primary specialty: Ophthalmic.
Browse the FDA 510(k) cleared devices submitted by Bioptigen, Inc. Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Underwriters Laboratories, Inc. as regulatory consultant.
FDA 510(k) Regulatory Record - Bioptigen, Inc.
4 devices
Cleared
Dec 09, 2016
EnFocus 2300, EnFocus 4400
Ophthalmic
67d
Cleared
Dec 02, 2015
EnFocus 2300, EnFocus 4400
Ophthalmic
257d
Cleared
May 11, 2012
ENVISU SPECTRAL DOMAIN OPHTHALMIC IMAGING SYSTEM (SDOIS)
Ophthalmic
123d
Cleared
Dec 13, 2006
BIOPTIGEN SPECTRAL DOMAIN OPHTHALMIC IMAGING SYSTEM
Ophthalmic
37d