FISHER DIAGNOSTICS KDA CALIBRATOR I

Calibrator, Multi-analyte Mixture

FISHER SCIENTIFIC CO., LLC.

The following data is part of a premarket notification filed by Fisher Scientific Co., Llc. with the FDA for Fisher Diagnostics Kda Calibrator I.

Pre-market Notification Details

Device IDK851150
510k NumberK851150
Device Name:FISHER DIAGNOSTICS KDA CALIBRATOR I
ClassificationCalibrator, Multi-analyte Mixture
Applicant FISHER SCIENTIFIC CO., LLC. 526 ROUTE 303 Orangeburg,  NY  10962
ContactCharles B Breuer
CorrespondentCharles B Breuer
FISHER SCIENTIFIC CO., LLC. 526 ROUTE 303 Orangeburg,  NY  10962
Product CodeJIX  
CFR Regulation Number862.1150 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-03-21
Decision Date1985-05-20

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