MYCOLOGY W/CYCLOHEXANIDE & CHLORAMPHEMICOL (C&C)

Culture Media, Selective And Non-differential

LAKEWOOD BIOCHEMICAL CO., INC.

The following data is part of a premarket notification filed by Lakewood Biochemical Co., Inc. with the FDA for Mycology W/cyclohexanide & Chloramphemicol (c&c).

Pre-market Notification Details

Device IDK873827
510k NumberK873827
Device Name:MYCOLOGY W/CYCLOHEXANIDE & CHLORAMPHEMICOL (C&C)
ClassificationCulture Media, Selective And Non-differential
Applicant LAKEWOOD BIOCHEMICAL CO., INC. 2111 IRVING BLVD. Dallas,  TX  75207
ContactJohn E Pedigo
CorrespondentJohn E Pedigo
LAKEWOOD BIOCHEMICAL CO., INC. 2111 IRVING BLVD. Dallas,  TX  75207
Product CodeJSJ  
CFR Regulation Number866.2360 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-09-21
Decision Date1987-10-08

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