INORGANIC PHOSPHORUS REAGENTS

5-amp-phosphate Release (colorimetric Test), 5'-nucleotidase

CONNECTICUT DIAGNOSTICS, LTD.

The following data is part of a premarket notification filed by Connecticut Diagnostics, Ltd. with the FDA for Inorganic Phosphorus Reagents.

Pre-market Notification Details

Device IDK811222
510k NumberK811222
Device Name:INORGANIC PHOSPHORUS REAGENTS
Classification5-amp-phosphate Release (colorimetric Test), 5'-nucleotidase
Applicant CONNECTICUT DIAGNOSTICS, LTD. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeCED  
CFR Regulation Number862.1520 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1981-05-04
Decision Date1981-05-21

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