DRUG STANDARDS

Calibrators, Drug Mixture

SUPELCO, INC.

The following data is part of a premarket notification filed by Supelco, Inc. with the FDA for Drug Standards.

Pre-market Notification Details

Device IDK833276
510k NumberK833276
Device Name:DRUG STANDARDS
ClassificationCalibrators, Drug Mixture
Applicant SUPELCO, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeDKB  
CFR Regulation Number862.3200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-09-22
Decision Date1984-01-01

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