Diagnostic Systems: FDA filings under this applicant name
FDA lists 14 510(k) clearances under the applicant name “Diagnostic Systems” (first 1983, latest 1991), across 13 product codes in 2 review panels. Median 510(k) review time under this name: 28 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 |
|---|---|---|---|
| JIT | Calibrator, Secondary | 2 | 2 |
| CEW | Radioimmunoassay, Parathyroid Hormone | 1 | 1 |
| CGA | Glucose Oxidase, Glucose | 1 | 1 |
| CGI | Radioimmunoassay, Estriol | 1 | 1 |
| CGS | Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes | 1 | 1 |
| CIT | Nadh Oxidation/Nad Reduction, Ast/Sgot | 1 | 1 |
| DKB | Calibrators, Drug Mixture | 1 | 1 |
| DNN | Calibrators, Ethyl Alcohol | 1 | 1 |
| JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | 1 | 1 |
| JQY | Ph Meter | 1 | 1 |
Plus 3 more product codes.
Review panels
Most recent Diagnostic Systems 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K905146 | OLYMPUS URINE PH | JQY | 1991-02-04 | 81 |
| K893691 | EMDS CREATINE KINASE ITEM NIMBER 65411 | CGS | 1989-08-31 | 107 |
| K893692 | EMDS ASPARTATE AMINOTRANSFERASE ITEM NUMBER 65405 | CIT | 1989-08-21 | 97 |
| K893966 | HDL PRECIPITATING REAGENT | LBR | 1989-07-25 | 53 |
| K884993 | VISUAL BLOOD GLUCOSE TEST SYSTEM | CGA | 1988-12-29 | 28 |
| K881116 | EASY-TEST EMIT(R) LIDOCAINE LIDO ITEM NO. 16641 | KLR | 1988-06-20 | 97 |
| K880787 | EASY-TEST LACTIC ACID (LA) | KHP | 1988-03-15 | 18 |
| K862403 | EMDS ANTIEPILEPTIC DRUG CALIBRATORS ITEM #67630/95 | DKB | 1986-07-11 | 15 |
| K854784 | ABSORBANCE (ABS) TEST PAK | JIT | 1985-12-19 | 20 |
| K853699 | EASY ANALYZER & EASY-TEST REAGENT | JJE | 1985-09-25 | 21 |
4 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Diagnostic Systems.
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.
- Diagnostic Products Corp. (324 510(k)s)
- Diagnostic Systems Laboratories, Inc. (94 510(k)s)
- Diagnostic Chemicals, Ltd. (Usa) (77 510(k)s)
- Diagnostic Chemicals , Ltd. (66 510(k)s)
- Diagnostic Reagents, Inc. (66 510(k)s)
- Diagnostic Hybrids, Inc. (36 510(k)s)
- Diagnostic Technology, Inc. (28 510(k)s)
- Diagnostic Solutions, Inc. (26 510(k)s)
- Diagnostic Ultrasound Corp. (16 510(k)s)
- Diagnostic Reagent Tech. (10 510(k)s)
- Diagnostic Specialties (8 510(k)s)
- Diagnostic Medical Instruments (5 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Diagnostic Systems?
FDA lists 14 510(k) clearances under the applicant name “Diagnostic Systems” (first 1983, latest 1991), across 13 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 Diagnostic Systems?
The median time from FDA receipt to decision across 510(k)s cleared under the name Diagnostic Systems is 28 days.
Which FDA product codes appear under Diagnostic Systems?
The most frequent FDA product codes under this applicant name are JIT (Calibrator, Secondary, 2); CEW (Radioimmunoassay, Parathyroid Hormone, 1); CGA (Glucose Oxidase, Glucose, 1).
Next steps
- See all 14 Diagnostic Systems clearances with predicates and recalls
- Run predicate analysis for product code JIT, Diagnostic Systems'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.