DULBECCO'S PBS POWDER

Formulations, Balanced Salt Solutions

DUTCHLAND LABORATORIES, INC.

The following data is part of a premarket notification filed by Dutchland Laboratories, Inc. with the FDA for Dulbecco's Pbs Powder.

Pre-market Notification Details

Device IDK820923
510k NumberK820923
Device Name:DULBECCO'S PBS POWDER
ClassificationFormulations, Balanced Salt Solutions
Applicant DUTCHLAND LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeKIP  
CFR Regulation Number864.2875 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1982-04-01
Decision Date1982-04-21

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