DONNECT. DIAG. CALCIUM DIAG. REAGENT

Cresolphthalein Complexone, Calcium

CONNECTICUT DIAGNOSTICS, LTD.

The following data is part of a premarket notification filed by Connecticut Diagnostics, Ltd. with the FDA for Donnect. Diag. Calcium Diag. Reagent.

Pre-market Notification Details

Device IDK792337
510k NumberK792337
Device Name:DONNECT. DIAG. CALCIUM DIAG. REAGENT
ClassificationCresolphthalein Complexone, Calcium
Applicant CONNECTICUT DIAGNOSTICS, LTD. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeCIC  
CFR Regulation Number862.1145 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1979-11-19
Decision Date1979-12-06

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