IN VITRO PHENOBARBITAL RIA TEST

Radioimmunoassay, Phenobarbital

CLINICAL ASSAYS, INC.

The following data is part of a premarket notification filed by Clinical Assays, Inc. with the FDA for In Vitro Phenobarbital Ria Test.

Pre-market Notification Details

Device IDK772111
510k NumberK772111
Device Name:IN VITRO PHENOBARBITAL RIA TEST
ClassificationRadioimmunoassay, Phenobarbital
Applicant CLINICAL ASSAYS, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeDKP  
CFR Regulation Number862.3660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1977-11-07
Decision Date1977-11-28

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