LYSE-TEC

Products, Red-cell Lysing Products

MEDILAB CORP.

The following data is part of a premarket notification filed by Medilab Corp. with the FDA for Lyse-tec.

Pre-market Notification Details

Device IDK840289
510k NumberK840289
Device Name:LYSE-TEC
ClassificationProducts, Red-cell Lysing Products
Applicant MEDILAB CORP. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeGGK  
CFR Regulation Number864.8540 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-01-24
Decision Date1984-03-05

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