Excel Scientific, Inc.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Excel Scientific, Inc.” (first 1996, latest 1997), across 5 product codes in 2 review panels. Median 510(k) review time under this name: 49 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 |
|---|---|---|---|
| LCX | Kit, Test, Pregnancy, Hcg, Over The Counter | 3 | 3 |
| JHI | Visual, Pregnancy Hcg, Prescription Use | 2 | 2 |
| CEP | Radioimmunoassay, Luteinizing Hormone | 1 | 1 |
| DHA | System, Test, Human Chorionic Gonadotropin | 1 | 1 |
| GTZ | Antisera, All Groups, Streptococcus Spp. | 1 | 1 |
Review panels
- Clinical Chemistry (7)
- Microbiology (1)
Most recent Excel Scientific, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K971286 | EZ SURE (EXCEL) URINE MIDSTREAM PREGNANCY HOME TEST | LCX | 1997-05-08 | 31 |
| K970467 | EZ SURE ONE STEP OVULATION PREDICTOR HOME TEST KIT | CEP | 1997-03-18 | 39 |
| K970425 | EZ SURE URINE DIPSTICK PREGNANCY HOME TEST | LCX | 1997-03-06 | 30 |
| K970424 | EXCEL ONE STEP URINE HCG PREGNANCY DIPSTICK TEST | JHI | 1997-03-06 | 30 |
| K963231 | EXCEL ONESTEP URINE HCG MODULE PREGNANCY TEST | JHI | 1996-12-04 | 107 |
| K962146 | EXCEL ONESTEP GROUP A STREP ANTIGEN MODULE TEST KIT | GTZ | 1996-10-07 | 126 |
| K962580 | EZ SURE ONESTEP EARLY PREGNANCY TEST | LCX | 1996-08-29 | 59 |
| K955707 | ONESTEP URINE/SERUM HCG MODULE PREGNANCY TEST KIT | DHA | 1996-05-02 | 139 |
Recalls
openFDA lists no recalls under a recalling firm named Excel Scientific, 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.
- Excel Tech. , Ltd. (58 510(k)s)
- Excel Health Care Products (5 510(k)s)
- Excel Medical, Inc. (5 510(k)s)
- Excel U.S.A. (3 510(k)s)
- Excel Medical Products, Inc. (2 510(k)s)
- Excel Mobility Products, Inc. (2 510(k)s)
- Excel Eyewear Corp. (1 510(k)s)
- Excel Glove Co., Ltd. (1 510(k)s)
- Excel Medical Electronics, LLC (1 510(k)s)
- Excel Medical Systems, Inc. (1 510(k)s)
- Excel Porcelain Products (1 510(k)s)
- Excel Rubber Products (M) Sdn. Bhd. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Excel Scientific, Inc.?
FDA lists 8 510(k) clearances under the applicant name “Excel Scientific, Inc.” (first 1996, latest 1997), across 5 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 Excel Scientific, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Excel Scientific, Inc. is 49 days.
Which FDA product codes appear under Excel Scientific, Inc.?
The most frequent FDA product codes under this applicant name are LCX (Kit, Test, Pregnancy, Hcg, Over The Counter, 3); JHI (Visual, Pregnancy Hcg, Prescription Use, 2); CEP (Radioimmunoassay, Luteinizing Hormone, 1).
Next steps
- See all 8 Excel Scientific, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LCX, Excel Scientific, 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.