IGE/THE OPHYLLINE CONTROL SERUM I,II,III

Multi-analyte Controls, All Kinds (assayed)

KALLESTAD LABORATORIES, INC.

The following data is part of a premarket notification filed by Kallestad Laboratories, Inc. with the FDA for Ige/the Ophylline Control Serum I,ii,iii.

Pre-market Notification Details

Device IDK822133
510k NumberK822133
Device Name:IGE/THE OPHYLLINE CONTROL SERUM I,II,III
ClassificationMulti-analyte Controls, All Kinds (assayed)
Applicant KALLESTAD LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeJJY  
CFR Regulation Number862.1660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1982-07-20
Decision Date1982-08-03

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