| Device ID | BK220746 |
| 510k Number | BK220746 |
| 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. |
| Classification | 510(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 Code | QTM |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SE) |
| Type | 510(k) Traditio |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-07-25 |
| Decision Date | 2022-10-14 |