SANDARE FAST 340 PHOSPHORUS PROCEDURE

5-amp-phosphate Release (colorimetric Test), 5'-nucleotidase

SANDARE CHEMICAL CO., INC.

The following data is part of a premarket notification filed by Sandare Chemical Co., Inc. with the FDA for Sandare Fast 340 Phosphorus Procedure.

Pre-market Notification Details

Device IDK812670
510k NumberK812670
Device Name:SANDARE FAST 340 PHOSPHORUS PROCEDURE
Classification5-amp-phosphate Release (colorimetric Test), 5'-nucleotidase
Applicant SANDARE CHEMICAL CO., INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeCED  
CFR Regulation Number862.1520 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1981-09-21
Decision Date1981-10-02

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