KALLESTAD RAST REAGENTS

System, Test, Radioallergosorbent (rast) Immunological

KALLESTAD LABORATORIES, INC.

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

Pre-market Notification Details

Device IDK820029
510k NumberK820029
Device Name:KALLESTAD RAST REAGENTS
ClassificationSystem, Test, Radioallergosorbent (rast) Immunological
Applicant KALLESTAD LABORATORIES, INC. 4221 Richmond Rd., N.W. Walker,  MI  49534
Product CodeDHB  
CFR Regulation Number866.5750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1982-01-05
Decision Date1982-04-06

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