DIRECT FA CONJUGATE FOR LEGIONELLA SP

Reagents, Antibody, Legionella, Direct & Indirect Fluorescent

SPRINGWOOD MICROBIOLOGICALS

The following data is part of a premarket notification filed by Springwood Microbiologicals with the FDA for Direct Fa Conjugate For Legionella Sp.

Pre-market Notification Details

Device IDK813339
510k NumberK813339
Device Name:DIRECT FA CONJUGATE FOR LEGIONELLA SP
ClassificationReagents, Antibody, Legionella, Direct & Indirect Fluorescent
Applicant SPRINGWOOD MICROBIOLOGICALS 803 N. Front St. Suite 3 McHenry,  IL  60050
Product CodeLHL  
CFR Regulation Number866.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1981-11-24
Decision Date1981-12-18

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