TEST, MACROGLOBULIN KIT (ALPHA2)

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KALLESTAD LABORATORIES, INC.

The following data is part of a premarket notification filed by Kallestad Laboratories, Inc. with the FDA for Test, Macroglobulin Kit (alpha2).

Pre-market Notification Details

Device IDK760396
510k NumberK760396
Device Name:TEST, MACROGLOBULIN KIT (ALPHA2)
Classification510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products   510(k) Premarket Notification Var MP = { Version: '1.0.22', Domains: {'es':'esp.fda.gov'}, SrcLang: 'en', UrlLang: 'mp_js_current_la
Applicant KALLESTAD LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product Code510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood &
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1976-08-06
Decision Date1976-08-26

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