BIOCIRCUITS IOS (IN-OFFICE SYSTEM)

Fluorometer, For Clinical Use

BIOCIRCUITS CORP.

The following data is part of a premarket notification filed by Biocircuits Corp. with the FDA for Biocircuits Ios (in-office System).

Pre-market Notification Details

Device IDK952719
510k NumberK952719
Device Name:BIOCIRCUITS IOS (IN-OFFICE SYSTEM)
ClassificationFluorometer, For Clinical Use
Applicant BIOCIRCUITS CORP. 1324 CHESAPEAKE TERR. Sunnyvale,  CA  94089
ContactSheila J Ramerman
CorrespondentSheila J Ramerman
BIOCIRCUITS CORP. 1324 CHESAPEAKE TERR. Sunnyvale,  CA  94089
Product CodeKHO  
CFR Regulation Number862.2560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-06-15
Decision Date1995-11-22
Summary:summary

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