OXALATE REAGENT

System, Test, Oxalate

SIGMA CHEMICAL CO.

The following data is part of a premarket notification filed by Sigma Chemical Co. with the FDA for Oxalate Reagent.

Pre-market Notification Details

Device IDK883525
510k NumberK883525
Device Name:OXALATE REAGENT
ClassificationSystem, Test, Oxalate
Applicant SIGMA CHEMICAL CO. P.O. BOX 14508 St. Louis,  MO  63178
ContactMathew Madappally
CorrespondentMathew Madappally
SIGMA CHEMICAL CO. P.O. BOX 14508 St. Louis,  MO  63178
Product CodeLPW  
CFR Regulation Number862.1542 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-08-17
Decision Date1988-10-25

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
05391516749640 K883525 000
05391516742177 K883525 000
05391516742184 K883525 000
05391516742191 K883525 000
05391516742207 K883525 000
05391516742214 K883525 000
05391516742221 K883525 000
05391516742238 K883525 000
05391516742245 K883525 000
05391516742160 K883525 000

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