MODIFICATION TO CARBON DIOXIDE-L3K ASSAY, CAT. NOS. 299-30, 299-17, 299-50, 299-80 AND 299-12

Enzymatic, Carbon-dioxide

DIAGNOSTIC CHEMICALS LTD.

The following data is part of a premarket notification filed by Diagnostic Chemicals Ltd. with the FDA for Modification To Carbon Dioxide-l3k Assay, Cat. Nos. 299-30, 299-17, 299-50, 299-80 And 299-12.

Pre-market Notification Details

Device IDK042362
510k NumberK042362
Device Name:MODIFICATION TO CARBON DIOXIDE-L3K ASSAY, CAT. NOS. 299-30, 299-17, 299-50, 299-80 AND 299-12
ClassificationEnzymatic, Carbon-dioxide
Applicant DIAGNOSTIC CHEMICALS LTD. 16 MCCARVILLE ST. Charlottetown,  CA C1e 2a6
ContactNancy Olscamp
CorrespondentNancy Olscamp
DIAGNOSTIC CHEMICALS LTD. 16 MCCARVILLE ST. Charlottetown,  CA C1e 2a6
Product CodeKHS  
CFR Regulation Number862.1160 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-08-31
Decision Date2004-12-27

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00628063400324 K042362 000
00628063400317 K042362 000
00628063400300 K042362 000
00628063400294 K042362 000
00628063400287 K042362 000
00628063400003 K042362 000

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