CDL AUTO-LYSING REAGENT

Products, Red-cell Lysing Products

CONNECTICUT DIAGNOSTICS, LTD.

The following data is part of a premarket notification filed by Connecticut Diagnostics, Ltd. with the FDA for Cdl Auto-lysing Reagent.

Pre-market Notification Details

Device IDK822504
510k NumberK822504
Device Name:CDL AUTO-LYSING REAGENT
ClassificationProducts, Red-cell Lysing Products
Applicant CONNECTICUT DIAGNOSTICS, LTD. 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 Received1982-08-19
Decision Date1982-09-17

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