SANDARE IRON PROCEDURE

Photometric Method, Iron (non-heme)

SANDARE CHEMICAL CO., INC.

The following data is part of a premarket notification filed by Sandare Chemical Co., Inc. with the FDA for Sandare Iron Procedure.

Pre-market Notification Details

Device IDK851394
510k NumberK851394
Device Name:SANDARE IRON PROCEDURE
ClassificationPhotometric Method, Iron (non-heme)
Applicant SANDARE CHEMICAL CO., INC. P.O. BOX 3028 Desoto,  TX  75115
ContactJames L Sanders
CorrespondentJames L Sanders
SANDARE CHEMICAL CO., INC. P.O. BOX 3028 Desoto,  TX  75115
Product CodeJIY  
CFR Regulation Number862.1410 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-04-09
Decision Date1985-04-30

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