TOBRAM E.R.A. TM

Radioimmunoassay, Amikacin

P-L BIOCHEMICALS, INC.

The following data is part of a premarket notification filed by P-l Biochemicals, Inc. with the FDA for Tobram E.r.a. Tm.

Pre-market Notification Details

Device IDK800517
510k NumberK800517
Device Name:TOBRAM E.R.A. TM
ClassificationRadioimmunoassay, Amikacin
Applicant P-L BIOCHEMICALS, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeKLQ  
CFR Regulation Number862.3035 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1980-03-05
Decision Date1980-03-20

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