BILE ACIDS CONTROLS

Single (specified) Analyte Controls (assayed And Unassayed)

SIGMA DIAGNOSTICS, INC.

The following data is part of a premarket notification filed by Sigma Diagnostics, Inc. with the FDA for Bile Acids Controls.

Pre-market Notification Details

Device IDK873342
510k NumberK873342
Device Name:BILE ACIDS CONTROLS
ClassificationSingle (specified) Analyte Controls (assayed And Unassayed)
Applicant SIGMA DIAGNOSTICS, INC. P.O. BOX 14508 St. Louis,  MO  63178
ContactMathew Madappally
CorrespondentMathew Madappally
SIGMA DIAGNOSTICS, INC. P.O. BOX 14508 St. Louis,  MO  63178
Product CodeJJX  
CFR Regulation Number862.1660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-08-19
Decision Date1987-10-20

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
05391516741897 K873342 000

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