The following data is part of a premarket notification filed by Mriglobal with the FDA for Applied Biosystems Bacillus Anthracis Detection Kit.
| Device ID | K183462 |
| 510k Number | K183462 |
| Device Name: | Applied Biosystems Bacillus Anthracis Detection Kit |
| 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 | MRIGlobal 425 Volker Boulevard Kansas City, MO 64110 |
| Contact | Fran White |
| Correspondent | Fran White MDC Associates, LLC 180 Cabot Street Beverly, MA 01915 |
| Product Code | QIF |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-12-14 |
| Decision Date | 2019-10-01 |
| Summary: | summary |