BIOSELF 101

Device, Fertility Diagnostic, Proceptive

BIOSELF, INC.

The following data is part of a premarket notification filed by Bioself, Inc. with the FDA for Bioself 101.

Pre-market Notification Details

Device IDK823209
510k NumberK823209
Device Name:BIOSELF 101
ClassificationDevice, Fertility Diagnostic, Proceptive
Applicant BIOSELF, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeLHD  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1982-10-28
Decision Date1983-02-15

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