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# 6 Medical Device Classification Notices
- URL: https://www.fdaweb.com/6-medical-device-classification-notices/
- Published: 2017-10-30T12:00:00.000Z
- Updated: 2026-09-14T22:58:53.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5139994

*Federal Register* notice: FDA has published the following six medical device classification notices: 

- Clinical chemistry and clinical toxicology devices — *De novo* [classification](https://www.gpo.gov/fdsys/pkg/FR-2017-10-30/pdf/2017-23491.pdf?ref=fdaweb.com) of Astute Medical’s Nephrocheck Acute Kidney Injury Test System.
- Immunology and microbiology devices — *De novo* [classification](https://www.gpo.gov/fdsys/pkg/FR-2017-10-30/pdf/2017-23513.pdf?ref=fdaweb.com) of Quidel Corp.’s Lyra Direct *Streptococcus* SPP Nucleic Acid-Based Assay.
- Immunology and microbiology devices — *De novo* [classification](https://www.gpo.gov/fdsys/pkg/FR-2017-10-30/pdf/2017-23489.pdf?ref=fdaweb.com) of Kronus, Inc.’ Aquaporin-4 Autoantibody ELISA Immunological Test System
- Immunology and microbiology devices — *De novo* [classification](https://www.gpo.gov/fdsys/pkg/FR-2017-10-30/pdf/2017-23496.pdf?ref=fdaweb.com) of Wallac Oy’s EnLite Neonatal TREC Newborn Screening Test for Severe Combined Immunodeficiency Disorder.
- Gastroenterology and urology devices — [Correction](https://www.gpo.gov/fdsys/pkg/FR-2017-10-30/pdf/2017-23490.pdf?ref=fdaweb.com) of *de novo* classification of the Oral Removable Palatal Space Occupying Device for Weight Management and/or Weight Loss. FDA has clarified that premarket notification is required for such devices.
- Neurological devices; [Correction](https://www.gpo.gov/fdsys/pkg/FR-2017-10-30/pdf/2017-23516.pdf?ref=fdaweb.com) of *de novo* classification of the Non-Electroencephalogram Physiological Signal Based Seizure Monitoring System. FDA has clarified that premarket notification is required for such devices.