A Device Indicated For Use In A Test System To Estimate Test Precision Or To Detect Systematic Analytical Deviations That May Arise From Reagent Or Analytical Instrument Variation.

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Grifols Diagnostic Solutions Inc.

The following data is part of a premarket notification filed by Grifols Diagnostic Solutions Inc. with the FDA for A Device Indicated For Use In A Test System To Estimate Test Precision Or To Detect Systematic Analytical Deviations That May Arise From Reagent Or Analytical Instrument Variation..

Pre-market Notification Details

Device IDBK220736
510k NumberBK220736
Device Name:A Device Indicated For Use In A Test System To Estimate Test Precision Or To Detect Systematic Analytical Deviations That May Arise From Reagent Or Analytical Instrument Variation.
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 Grifols Diagnostic Solutions Inc. 4560 Horton Street, M/s N-200 Emeryville,  CA  94608 2916
Product CodeQTM
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SE)
Type510(k) Traditio
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-06-24
Decision Date2022-09-16

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