Diagnostic Specialties: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Diagnostic Specialties” (first 1981, latest 1997), across 8 product codes in 2 review panels. Median 510(k) review time under this name: 68 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 |
|---|---|---|---|
| CEJ | Tetraphenyl Borate, Colorimetry, Potassium | 1 | 1 |
| CGA | Glucose Oxidase, Glucose | 1 | 1 |
| GIS | Test, Fibrinogen | 1 | 1 |
| JHJ | Agglutination Method, Human Chorionic Gonadotropin | 1 | 1 |
| JIQ | Turbidimetric Method, Protein Or Albumin (Urinary, Non-Quant.) | 1 | 1 |
| JIR | Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) | 1 | 1 |
| LCP | Assay, Glycosylated Hemoglobin | 1 | 1 |
| LCX | Kit, Test, Pregnancy, Hcg, Over The Counter | 1 | 1 |
Review panels
- Clinical Chemistry (6)
- Hematology (2)
Most recent Diagnostic Specialties 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K971458 | ENZIP IMMUNOTURBIDIMETRIC MICROALBUMIN ASSAY KIT | JIQ | 1997-09-02 | 133 |
| K941001 | ENZIP IMMUNOTURBIDMETRIC FIBRINOGEN ASSAY KIT | GIS | 1994-08-30 | 182 |
| K930823 | PROTEIN-BOUND GLUCOSE ASSAYN KIT | LCP | 1993-08-19 | 183 |
| K922032 | ENZIP URINARY MICROALBUMIN TEST | JIR | 1992-07-30 | 90 |
| K831180 | PREGNA-CERT, SLIDE PREGNANCY TEST | JHJ | 1983-05-27 | 46 |
| K823109 | GENERIC PREGNANCY TEST | LCX | 1982-11-10 | 20 |
| K813608 | POTASSIUM REAGENT SET | CEJ | 1982-01-22 | 24 |
| K813412 | GLUCOSE ENZYME-COLOR REAGENT SET | CGA | 1981-12-31 | 27 |
Recalls
openFDA lists no recalls under a recalling firm named Diagnostic Specialties.
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 Systems (14 510(k)s)
- Diagnostic Reagent Tech. (10 510(k)s)
- Diagnostic Medical Instruments (5 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Diagnostic Specialties?
FDA lists 8 510(k) clearances under the applicant name “Diagnostic Specialties” (first 1981, latest 1997), across 8 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 Specialties?
The median time from FDA receipt to decision across 510(k)s cleared under the name Diagnostic Specialties is 68 days.
Which FDA product codes appear under Diagnostic Specialties?
The most frequent FDA product codes under this applicant name are CEJ (Tetraphenyl Borate, Colorimetry, Potassium, 1); CGA (Glucose Oxidase, Glucose, 1); GIS (Test, Fibrinogen, 1).
Next steps
- See all 8 Diagnostic Specialties clearances with predicates and recalls
- Run predicate analysis for product code CEJ, Diagnostic Specialties'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.