Miles Laboratories, Inc.: FDA filings under this applicant name
FDA lists 158 510(k) clearances under the applicant name “Miles Laboratories, Inc.” (first 1976, latest 1988), plus 1 PMA decision, across 98 product codes in 9 review panels. Median 510(k) review time under this name: 38 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 |
|---|---|---|---|
| CGA | Glucose Oxidase, Glucose | 12 | 12 |
| JQP | Calculator/Data Processing Module, For Clinical Use | 8 | 8 |
| KQO | Automated Urinalysis System | 6 | 6 |
| CDX | Radioimmunoassay, Total Thyroxine | 4 | 4 |
| IEO | Processor, Tissue, Automated | 4 | 4 |
| KHG | Whole Blood Hemoglobin Determination | 4 | 4 |
| DJB | Radioimmunoassay, Gentamicin (125-I), Second Antibody Sep. | 3 | 3 |
| JIL | Method, Enzymatic, Glucose (Urinary, Non-Quantitative) | 3 | 3 |
| JJW | Urinalysis Controls (Assayed And Unassayed) | 3 | 3 |
| KHQ | Radioassay, Triiodothyronine Uptake | 3 | 3 |
Plus 88 more product codes.
Review panels
- Clinical Chemistry (77)
- Clinical Toxicology (37)
- Hematology (10)
- Immunology (10)
- Pathology (10)
- Microbiology (8)
- General Hospital (3)
- Dental (1)
- General and Plastic Surgery (1)
Most recent Miles Laboratories, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K880605 | LABELING CHANGE FOR CUTTER PUREFLO PLUS IV FILTER | FPB | 1988-05-26 | 104 |
| K874909 | MICRO-BUMINTEST REAGENT TABLETS | JIR | 1988-04-28 | 149 |
| K875079 | MODIFIED SERALYZER ALT/SGPT REAG. STRIPS & MODULE | CKA | 1988-04-05 | 118 |
| K871835 | GLUCOMETER QC BLOOD METER, AMES GLUCO SYSTEM PRINT | CGA | 1987-12-22 | 225 |
| K872120 | SERALYZER III BLOOD CHEMISTRY ANALYZER | JJF | 1987-10-28 | 149 |
| K873304 | CLINITEK AUTO 2000 REAGENT CASSETTE (LEUKOCYTES) | LJX | 1987-09-11 | 24 |
| K872634 | CUTTER PUREFLO PLUS IV FILTER | FPB | 1987-08-04 | 29 |
| K870214 | MODIFIED SALTEX REAGENT STRIPS | CHK | 1987-06-29 | 160 |
| K870752 | SERALYZER LDH/TOTAL BILIRUBIN/TRIGLYCERIDES STRIPS | CFJ | 1987-04-14 | 48 |
| K865053 | SERA-TEK MICROSOMAL ANTIBODY TEST | JZO | 1987-02-18 | 56 |
148 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P800032 | PMA | BIOSTATOR GLUCOSE CONTROLLER | 1981-05-28 |
Recalls
openFDA lists no recalls under a recalling firm named Miles Laboratories, 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, Inc. (11 510(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 Laboratories, Inc.?
FDA lists 158 510(k) clearances under the applicant name “Miles Laboratories, Inc.” (first 1976, latest 1988), plus 1 PMA decision, across 98 product codes in 9 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 Laboratories, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Miles Laboratories, Inc. is 38 days.
Which FDA product codes appear under Miles Laboratories, Inc.?
The most frequent FDA product codes under this applicant name are CGA (Glucose Oxidase, Glucose, 12); JQP (Calculator/Data Processing Module, For Clinical Use, 8); KQO (Automated Urinalysis System, 6).
Next steps
- See all 158 Miles Laboratories, Inc. clearances with predicates and recalls
- Run predicate analysis for product code CGA, Miles Laboratories, 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, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.