H 10 OR HEMATIL 10 BLOOD CELL & PLATELET COUNTER

Counter, Differential Cell

TEXAS INTL. LABORATORIES, INC.

The following data is part of a premarket notification filed by Texas Intl. Laboratories, Inc. with the FDA for H 10 Or Hematil 10 Blood Cell & Platelet Counter.

Pre-market Notification Details

Device IDK883177
510k NumberK883177
Device Name:H 10 OR HEMATIL 10 BLOOD CELL & PLATELET COUNTER
ClassificationCounter, Differential Cell
Applicant TEXAS INTL. LABORATORIES, INC. 5601 BINTLIFF SUITE 500 Houston,  TX  77036
ContactRobert Cogan
CorrespondentRobert Cogan
TEXAS INTL. LABORATORIES, INC. 5601 BINTLIFF SUITE 500 Houston,  TX  77036
Product CodeGKZ  
CFR Regulation Number864.5220 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-07-27
Decision Date1988-11-30

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.