HISTOCHEMICAL AFB DEMONSTRATION

Carbol Fuchsin

HARLECO

The following data is part of a premarket notification filed by Harleco with the FDA for Histochemical Afb Demonstration.

Pre-market Notification Details

Device IDK771390
510k NumberK771390
Device Name:HISTOCHEMICAL AFB DEMONSTRATION
ClassificationCarbol Fuchsin
Applicant HARLECO 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeICL  
CFR Regulation Number864.1850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1977-07-27
Decision Date1977-08-22

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