Scripps-Miles, Inc.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Scripps-Miles, Inc.” (first 1981, latest 1981), across 6 product codes in 1 review panel. Median 510(k) review time under this name: 25 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DEW | Igg, Antigen, Antiserum, Control | 2 | 2 |
| DHN | Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control | 2 | 2 |
| DHR | System, Test, Rheumatoid Factor | 2 | 2 |
| CZW | Complement C3, Antigen, Antiserum, Control | 1 | 1 |
| DBI | Complement C4, Antigen, Antiserum, Control | 1 | 1 |
| DHL | Protein, Complement, Antigen, Antiserum, Control | 1 | 1 |
Review panels
- Immunology (9)
Most recent Scripps-Miles, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K812453 | SCRIPPSYSTEM IMMUNOGLOBIN RID KIT | DEW | 1981-09-23 | 26 |
| K812328 | SCRIPPSYSTEM NEPHELOMETRIC ANTISERA KIT | DEW | 1981-09-08 | 21 |
| K811714 | HEP-2-CRITHIDIA LUCILIAE ANA TEST KIT | DHN | 1981-07-10 | 23 |
| K811433 | SCRIPPSERA COMPLEMENT CONTROL SERA | DHL | 1981-06-16 | 25 |
| K810502 | SCRIPPSYSTEM C4 RID KIT | DBI | 1981-04-08 | 43 |
| K810501 | SCRIPPSYSTEM C3 RID KIT | CZW | 1981-04-08 | 43 |
| K810221 | SCRIPPSERA THEUMATOID FACTOR REFER. CNTL | DHR | 1981-02-09 | 13 |
| K810141 | SCRIPPSYSTEM RHEUMATOID FACTOR LATEX KIT | DHR | 1981-02-09 | 19 |
| K810081 | SCRIPPSERA ANA REFERENCE CONTROL SERA | DHN | 1981-02-09 | 27 |
Recalls
openFDA lists no recalls under a recalling firm named Scripps-Miles, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Scripps Laboratories, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Scripps-Miles, Inc.?
FDA lists 9 510(k) clearances under the applicant name “Scripps-Miles, Inc.” (first 1981, latest 1981), across 6 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Scripps-Miles, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Scripps-Miles, Inc. is 25 days.
Which FDA product codes appear under Scripps-Miles, Inc.?
The most frequent FDA product codes under this applicant name are DEW (Igg, Antigen, Antiserum, Control, 2); DHN (Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control, 2); DHR (System, Test, Rheumatoid Factor, 2).
Next steps
- See all 9 Scripps-Miles, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DEW, Scripps-Miles, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.