QUANTIFY(901)

Urinalysis Controls (assayed And Unassayed)

HEMATRONIX, INC.

The following data is part of a premarket notification filed by Hematronix, Inc. with the FDA for Quantify(901).

Pre-market Notification Details

Device IDK972710
510k NumberK972710
Device Name:QUANTIFY(901)
ClassificationUrinalysis Controls (assayed And Unassayed)
Applicant HEMATRONIX, INC. 524 STONE RD. SUITE A Benicia,  CA  94510
ContactJames D Lapicola
CorrespondentJames D Lapicola
HEMATRONIX, INC. 524 STONE RD. SUITE A Benicia,  CA  94510
Product CodeJJW  
CFR Regulation Number862.1660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-07-21
Decision Date1997-08-15
Summary:summary

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