EMIT-AMD AMIKACIN ASSAY

Radioimmunoassay, Amikacin

DADE BEHRING, INC.

The following data is part of a premarket notification filed by Dade Behring, Inc. with the FDA for Emit-amd Amikacin Assay.

Pre-market Notification Details

Device IDK822657
510k NumberK822657
Device Name:EMIT-AMD AMIKACIN ASSAY
ClassificationRadioimmunoassay, Amikacin
Applicant DADE BEHRING, INC. P.O. BOX 6101 Newark,  DE  19714
ContactYuk-ting Lewis
CorrespondentYuk-ting Lewis
DADE BEHRING, INC. P.O. BOX 6101 Newark,  DE  19714
Product CodeKLQ  
CFR Regulation Number862.3035 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1982-09-03
Decision Date1982-09-28

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00842768001543 K822657 000

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