Alpha-Tec Systems, Inc.: FDA filings under this applicant name
FDA lists 18 510(k) clearances under the applicant name “Alpha-Tec Systems, Inc.” (first 1983, latest 2006), across 9 product codes in 2 review panels. Median 510(k) review time under this name: 26 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 |
|---|---|---|---|
| JTS | Stains, Microbiologic | 5 | 5 |
| LJG | Quality Control Slides | 4 | 4 |
| JSK | Supplement, Culture Media | 2 | 2 |
| LDZ | Fixative, Alcohol Containing | 2 | 2 |
| ICL | Carbol Fuchsin | 1 | 1 |
| JSY | Kit, Identification, Mycobacteria | 1 | 1 |
| KEL | Adhesive, Albumin-Based | 1 | 1 |
| LDW | Fixative, Acid Containing | 1 | 1 |
| LKS | Device, Parasite Concentration | 1 | 1 |
Review panels
- Microbiology (13)
- Pathology (5)
Most recent Alpha-Tec Systems, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K053257 | PARA-PRO FC50 | LKS | 2006-05-12 | 171 |
| K890861 | ATS DOBELL & O'CONNOR'S IODINE | JTS | 1989-03-23 | 30 |
| K890020 | ATS LUGOL'S IODINE SOLUTION | JTS | 1989-02-24 | 51 |
| K890148 | ATS TB RAPID STAIN SET PRODUCT #034-45 | ICL | 1989-01-24 | 11 |
| K890022 | ATS MAYER'S ALBUMIN | KEL | 1989-01-10 | 6 |
| K883049 | ATS PARA-SET IODINE ALCOHOL SOLUTION | JTS | 1988-08-17 | 29 |
| K883048 | ATS PARA-SET MODIFIED PVA FIXATIVE SOLUTION | LDZ | 1988-08-17 | 32 |
| K883062 | ATS SCHAUDINN'S FIXATIVE W/ACETIC ACID | LDW | 1988-08-04 | 16 |
| K881949 | ATS NAC-PAC SET | JSK | 1988-05-25 | 15 |
| K881879 | ATS M/15 PHOSPHATE BUFFER, PRODUCT #034-42 | JSK | 1988-05-13 | 9 |
8 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Alpha-Tec Systems, 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Alpha-Tec Systems, Inc.?
FDA lists 18 510(k) clearances under the applicant name “Alpha-Tec Systems, Inc.” (first 1983, latest 2006), across 9 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 Alpha-Tec Systems, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Alpha-Tec Systems, Inc. is 26 days.
Which FDA product codes appear under Alpha-Tec Systems, Inc.?
The most frequent FDA product codes under this applicant name are JTS (Stains, Microbiologic, 5); LJG (Quality Control Slides, 4); JSK (Supplement, Culture Media, 2).
Next steps
- See all 18 Alpha-Tec Systems, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JTS, Alpha-Tec Systems, 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.