BIOTIS ABNORMAL CLINICAL CHEM SERUM-

Multi-analyte Controls, All Kinds (assayed)

OTISVILLE BIOTECH, INC.

The following data is part of a premarket notification filed by Otisville Biotech, Inc. with the FDA for Biotis Abnormal Clinical Chem Serum-.

Pre-market Notification Details

Device IDK840458
510k NumberK840458
Device Name:BIOTIS ABNORMAL CLINICAL CHEM SERUM-
ClassificationMulti-analyte Controls, All Kinds (assayed)
Applicant OTISVILLE BIOTECH, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeJJY  
CFR Regulation Number862.1660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-02-02
Decision Date1984-04-17

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.