IRON PROCEDURE

Photometric Method, Iron (non-heme)

DATA MEDICAL ASSOCIATES, INC.

The following data is part of a premarket notification filed by Data Medical Associates, Inc. with the FDA for Iron Procedure.

Pre-market Notification Details

Device IDK863266
510k NumberK863266
Device Name:IRON PROCEDURE
ClassificationPhotometric Method, Iron (non-heme)
Applicant DATA MEDICAL ASSOCIATES, INC. 845 AVENUE G EAST Arlington,  TX  76011
ContactMarjorie B Potts
CorrespondentMarjorie B Potts
DATA MEDICAL ASSOCIATES, INC. 845 AVENUE G EAST Arlington,  TX  76011
Product CodeJIY  
CFR Regulation Number862.1410 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-08-25
Decision Date1986-09-11

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