KALLESTAD ANTISERA TO PHENOBARBITAL

Enzyme Immunoassay, Phenobarbital

KALLESTAD LABORATORIES, INC.

The following data is part of a premarket notification filed by Kallestad Laboratories, Inc. with the FDA for Kallestad Antisera To Phenobarbital.

Pre-market Notification Details

Device IDK811367
510k NumberK811367
Device Name:KALLESTAD ANTISERA TO PHENOBARBITAL
ClassificationEnzyme Immunoassay, Phenobarbital
Applicant KALLESTAD LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeDLZ  
CFR Regulation Number862.3660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1981-05-14
Decision Date1981-05-29

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