FLOW PAC TOTAL IRON REAGENTS:2183,2349,2312,014339

Photometric Method, Iron (non-heme)

AMERICAN RESEARCH PRODUCTS CO.

The following data is part of a premarket notification filed by American Research Products Co. with the FDA for Flow Pac Total Iron Reagents:2183,2349,2312,014339.

Pre-market Notification Details

Device IDK871284
510k NumberK871284
Device Name:FLOW PAC TOTAL IRON REAGENTS:2183,2349,2312,014339
ClassificationPhotometric Method, Iron (non-heme)
Applicant AMERICAN RESEARCH PRODUCTS CO. 30175 SOLON INDUSTRIAL PKWY. P.O. BOX 39098 Solon,  OH  44139
ContactJ. A Levey
CorrespondentJ. A Levey
AMERICAN RESEARCH PRODUCTS CO. 30175 SOLON INDUSTRIAL PKWY. P.O. BOX 39098 Solon,  OH  44139
Product CodeJIY  
CFR Regulation Number862.1410 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-03-31
Decision Date1987-04-08

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