SANDARE LYOPHILIZED HEMOGLOBIN CONTROLS

Mixture, Hematology Quality Control

SANDARE CHEMICAL CO., INC.

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

Pre-market Notification Details

Device IDK800780
510k NumberK800780
Device Name:SANDARE LYOPHILIZED HEMOGLOBIN CONTROLS
ClassificationMixture, Hematology Quality Control
Applicant SANDARE CHEMICAL CO., INC. 4221 Richmond Rd., N.W. Walker,  MI  49534
Product CodeJPK  
CFR Regulation Number864.8625 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1980-04-08
Decision Date1980-04-24

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00811727011497 K800780 000

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