Miles, Inc.: FDA filings under this applicant name
FDA lists 11 510(k) clearances under the applicant name “Miles, Inc.” (first 1993, latest 1995), across 9 product codes in 2 review panels. Median 510(k) review time under this name: 80 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 |
|---|---|---|---|
| GKZ | Counter, Differential Cell | 3 | 3 |
| CGN | Acid, Folic, Radioimmunoassay | 1 | 1 |
| CGX | Alkaline Picrate, Colorimetry, Creatinine | 1 | 1 |
| JFJ | Catalytic Methods, Amylase | 1 | 1 |
| JHW | U.V. Method, Cpk Isoenzymes | 1 | 1 |
| JIY | Photometric Method, Iron (Non-Heme) | 1 | 1 |
| JJC | Analyzer, Chemistry (Sequential Multiple, Continuous Flow) Clinical Use | 1 | 1 |
| JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | 1 | 1 |
| KHS | Enzymatic, Carbon-Dioxide | 1 | 1 |
Review panels
- Clinical Chemistry (8)
- Hematology (3)
Most recent Miles, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K950292 | FOLATE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM, IN VITRO DIAGNOSTIC SYSTEM | CGN | 1995-05-02 | 97 |
| K950353 | TECHNICON IMMUNO 1(R) SYSTEM IN-VITRO DIAGNOSTIC SYSTEM | JJE | 1995-04-20 | 80 |
| K950186 | CK-MB METHOD FOR THE TECHNICON IMMUNO 1(R) SYSTEM IN-VITRO DIAGNOSTIC SYSTEM | JHW | 1995-03-13 | 55 |
| K945655 | CREATININE (ENZYMATIC UV) PROCEDURE FOR TECHNICON SYSTEMS (IN VITRO DIAGNOSTIC TEST SYSTEM) | CGX | 1995-01-05 | 49 |
| K941171 | TECHNICON H* 3 RTC SYSTEM (IN-VITRO DIAGNOSTIC SYSTEM) | GKZ | 1994-12-14 | 275 |
| K943376 | OPERA SYSTEM | JJC | 1994-09-14 | 63 |
| K941156 | TECHNISON AXON SYSTEM | KHS | 1994-04-26 | 47 |
| K933682 | DIRECT AMYLASE (EC 3.2.1.1) METHOD FOR TECHNICON SYSTEMS | JFJ | 1994-04-12 | 257 |
| K935287 | IRON -II (FE-II) METHOD/TECH CHEM 1(R) 1+TM SYSTEM | JIY | 1994-01-03 | 61 |
| K933478 | TECHNICON H*1 SYSTEMS, LABFACTS SOFTWARE FOR U.I.W. VERSIONS 4.11 & 5.11 | GKZ | 1993-11-22 | 129 |
1 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named 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.
- Miles Laboratories, Inc. (158 510(k)s)
- Miles Inc., Agfa Division (2 510(k)s)
- Miles Inc., Dental Products (2 510(k)s)
- Miles Pharmaceuticals (2 510(k)s)
- Miles Diagnostics Div. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Miles, Inc.?
FDA lists 11 510(k) clearances under the applicant name “Miles, Inc.” (first 1993, latest 1995), across 9 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Miles, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Miles, Inc. is 80 days.
Which FDA product codes appear under Miles, Inc.?
The most frequent FDA product codes under this applicant name are GKZ (Counter, Differential Cell, 3); CGN (Acid, Folic, Radioimmunoassay, 1); CGX (Alkaline Picrate, Colorimetry, Creatinine, 1).
Next steps
- See all 11 Miles, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GKZ, 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.