Apple Diagnostic Products: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Apple Diagnostic Products” (first 1984, latest 1985), across 6 product codes in 2 review panels. Median 510(k) review time under this name: 40 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 |
|---|---|---|---|
| DHN | Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control | 2 | 2 |
| GLZ | Antigens, If, Toxoplasma Gondii | 1 | 1 |
| KTL | Anti-Dna Indirect Immunofluorescent Solid Phase | 1 | 1 |
| LJC | Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group) | 1 | 1 |
| LJM | Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls | 1 | 1 |
| LJP | Antiserum, Fluorescent, Chlamydia Trachomatis | 1 | 1 |
Review panels
- Immunology (4)
- Microbiology (3)
Most recent Apple Diagnostic Products 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K844287 | ADPIFA TEST FOR ANTIBODIES TO TOXOPLASMA GONDII | GLZ | 1985-01-07 | 63 |
| K843745 | ADP ANA APPLEZYME | LJM | 1984-10-25 | 30 |
| K843120 | APPLELISA CHLAMYDIA TRACHOMATIS ANTI | LJC | 1984-09-12 | 35 |
| K842707 | ADP NDNA IFA TEST | KTL | 1984-08-21 | 40 |
| K842183 | ADP ANA IFA TEST | DHN | 1984-06-22 | 21 |
| K834241 | ANA APPLELISA | DHN | 1984-04-04 | 120 |
| K834242 | ADP IFA TEST FOR CHLAMYDIAE TRACHOMATIS | LJP | 1984-03-02 | 87 |
Recalls
openFDA lists no recalls under a recalling firm named Apple Diagnostic Products.
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.
- Apple, Inc. (9 510(k)s)
- Apple Medical Corp. (9 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Apple Diagnostic Products?
FDA lists 7 510(k) clearances under the applicant name “Apple Diagnostic Products” (first 1984, latest 1985), across 6 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 Apple Diagnostic Products?
The median time from FDA receipt to decision across 510(k)s cleared under the name Apple Diagnostic Products is 40 days.
Which FDA product codes appear under Apple Diagnostic Products?
The most frequent FDA product codes under this applicant name are DHN (Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control, 2); GLZ (Antigens, If, Toxoplasma Gondii, 1); KTL (Anti-Dna Indirect Immunofluorescent Solid Phase, 1).
Next steps
- See all 7 Apple Diagnostic Products clearances with predicates and recalls
- Run predicate analysis for product code DHN, Apple Diagnostic Products'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.