CARBON DIOXIDE ASSAY KIT (ENZYMATIC) 201-18/202-18

Enzymatic, Carbon-dioxide

DIAGNOSTIC CHEMICALS, LTD. (USA)

The following data is part of a premarket notification filed by Diagnostic Chemicals, Ltd. (usa) with the FDA for Carbon Dioxide Assay Kit (enzymatic) 201-18/202-18.

Pre-market Notification Details

Device IDK880868
510k NumberK880868
Device Name:CARBON DIOXIDE ASSAY KIT (ENZYMATIC) 201-18/202-18
ClassificationEnzymatic, Carbon-dioxide
Applicant DIAGNOSTIC CHEMICALS, LTD. (USA) 435 MAIN ST. Monroe,  CT  06468
ContactDavid Templeton
CorrespondentDavid Templeton
DIAGNOSTIC CHEMICALS, LTD. (USA) 435 MAIN ST. Monroe,  CT  06468
Product CodeKHS  
CFR Regulation Number862.1160 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-03-01
Decision Date1988-11-01

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