SPECTRONIC 501 & 601 - CLINICAL SPECTROPHOTOMETER

Colorimeter, Photometer, Spectrophotometer For Clinical Use

BAUSCH & LOMB, INC.

The following data is part of a premarket notification filed by Bausch & Lomb, Inc. with the FDA for Spectronic 501 & 601 - Clinical Spectrophotometer.

Pre-market Notification Details

Device IDK850709
510k NumberK850709
Device Name:SPECTRONIC 501 & 601 - CLINICAL SPECTROPHOTOMETER
ClassificationColorimeter, Photometer, Spectrophotometer For Clinical Use
Applicant BAUSCH & LOMB, INC. 1400 NORTH GOODMAN ST. P.O.BOX 450 Rochester,  NY  14692
ContactNicholas A Walp
CorrespondentNicholas A Walp
BAUSCH & LOMB, INC. 1400 NORTH GOODMAN ST. P.O.BOX 450 Rochester,  NY  14692
Product CodeJJQ  
CFR Regulation Number862.2300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-02-22
Decision Date1985-03-12

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