ALBUMIN STANDARD, #65070

Calibrator, Secondary

EMD CHEMICALS INC.

The following data is part of a premarket notification filed by Emd Chemicals Inc. with the FDA for Albumin Standard, #65070.

Pre-market Notification Details

Device IDK822478
510k NumberK822478
Device Name:ALBUMIN STANDARD, #65070
ClassificationCalibrator, Secondary
Applicant EMD CHEMICALS INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeJIT  
CFR Regulation Number862.1150 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1982-08-17
Decision Date1982-09-14

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