Smithkline Diagnostics, Inc.: FDA filings under this applicant name
FDA lists 42 510(k) clearances under the applicant name “Smithkline Diagnostics, Inc.” (first 1976, latest 1996), across 24 product codes in 8 review panels. Median 510(k) review time under this name: 35 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 |
|---|---|---|---|
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 5 | 5 |
| JHS | Differential Rate Kinetic Method, Cpk Or Isoenzymes | 4 | 4 |
| KHE | Reagent, Occult Blood | 4 | 4 |
| CFJ | Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase | 3 | 3 |
| CDT | Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides | 2 | 2 |
| CFR | Hexokinase, Glucose | 2 | 2 |
| CHH | Enzymatic Esterase--Oxidase, Cholesterol | 2 | 2 |
| CIT | Nadh Oxidation/Nad Reduction, Ast/Sgot | 2 | 2 |
| CKA | Nadh Oxidation/Nad Reduction, Alt/Sgpt | 2 | 2 |
| LYR | Helicobacter Pylori | 2 | 2 |
Plus 14 more product codes.
Review panels
- Clinical Chemistry (24)
- Radiology (5)
- Hematology (4)
- Microbiology (3)
- Obstetrics and Gynecology (3)
- Cardiovascular (1)
- Gastroenterology and Urology (1)
- Clinical Toxicology (1)
Most recent Smithkline Diagnostics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K961062 | FLEXSURE OBT | KHE | 1996-11-06 | 233 |
| K960183 | FLEXSURE HP,CONTROLS FOR FLEXSUREHP,FLEXPACK HP(ABBOTT DIAGNOSTICS)ANDCONTROLS FOR FLEXPACK HP (ABBOTT DIAGNOSTICS) | LYR | 1996-06-07 | 143 |
| K934863 | FLEXSURE HP | LYR | 1994-05-18 | 218 |
| K880499 | HEMOCCULT SENSITIVE TEST | KHE | 1988-05-23 | 108 |
| K875131 | (SKD) CHOLESTEROL TEST KIT | CHH | 1988-03-01 | 77 |
| K862849 | HEMOCCULT WIPE TEST | KHE | 1986-12-09 | 133 |
| K854723 | SKD ELECTROCHEMICAL SYSTEM (ECS) | CEM | 1986-03-05 | 103 |
| K852841 | RAPID DIRECT STREP A LATEX AGGLUTINATION TEST | GTZ | 1985-07-24 | 19 |
| K821884 | GASTROCCULT TM | KHE | 1982-10-08 | 105 |
| K821674 | SPINCHEM ACID PHOSPHATASE REAGENT | CKB | 1982-06-22 | 15 |
32 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Smithkline Diagnostics, 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.
- Smithkline Beecham Corp. (1 510(k)s)
- Smithkline Beecham Consumer Healthcare Products (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Smithkline Diagnostics, Inc.?
FDA lists 42 510(k) clearances under the applicant name “Smithkline Diagnostics, Inc.” (first 1976, latest 1996), across 24 product codes in 8 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 Smithkline Diagnostics, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Smithkline Diagnostics, Inc. is 35 days.
Which FDA product codes appear under Smithkline Diagnostics, Inc.?
The most frequent FDA product codes under this applicant name are IYO (System, Imaging, Pulsed Echo, Ultrasonic, 5); JHS (Differential Rate Kinetic Method, Cpk Or Isoenzymes, 4); KHE (Reagent, Occult Blood, 4).
Next steps
- See all 42 Smithkline Diagnostics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code IYO, Smithkline Diagnostics, 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.