CULTURETTE BRAND PVA

Solution, Carnoy's

MARION LABORATORIES, INC.

The following data is part of a premarket notification filed by Marion Laboratories, Inc. with the FDA for Culturette Brand Pva.

Pre-market Notification Details

Device IDK790815
510k NumberK790815
Device Name:CULTURETTE BRAND PVA
ClassificationSolution, Carnoy's
Applicant MARION LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeIGM  
CFR Regulation Number864.4010 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1979-04-27
Decision Date1979-05-15

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