BIOTROL IRON REAGENT

Photometric Method, Iron (non-heme)

BIOTROL, USA, INC.

The following data is part of a premarket notification filed by Biotrol, Usa, Inc. with the FDA for Biotrol Iron Reagent.

Pre-market Notification Details

Device IDK890395
510k NumberK890395
Device Name:BIOTROL IRON REAGENT
ClassificationPhotometric Method, Iron (non-heme)
Applicant BIOTROL, USA, INC. 113 BRANYWINE PKWY. Westchester,  PA  19380
ContactAllan C Murphy
CorrespondentAllan C Murphy
BIOTROL, USA, INC. 113 BRANYWINE PKWY. Westchester,  PA  19380
Product CodeJIY  
CFR Regulation Number862.1410 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-01-25
Decision Date1989-03-08

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