International Newtech Development, Inc.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “International Newtech Development, Inc.” (first 1995, latest 2000), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 120 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 |
|---|---|---|---|
| JHI | Visual, Pregnancy Hcg, Prescription Use | 5 | 5 |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | 1 |
| JMT | Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) | 1 | 1 |
| LCX | Kit, Test, Pregnancy, Hcg, Over The Counter | 1 | 1 |
Review panels
Most recent International Newtech Development, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K993850 | URINALYSIS REAGENT STRIPS (10 PARAMETERS) | JMT | 2000-01-03 | 52 |
| K974060 | MINISTRIP/ SERUM AND URINE COMBO HCG TEST | JHI | 1998-04-09 | 164 |
| K974059 | ONE STEP MIDSTREAM HCG PREGNANCY TEST | LCX | 1998-04-09 | 164 |
| K974009 | PS-UNIT CASSETTE/SERUM AND URINE COMBO HCG | JHI | 1998-03-13 | 143 |
| K970176 | HCG CONTROLS | JJX | 1997-02-06 | 20 |
| K963133 | PS-UNIT CASSETTE/SERUM HCG | JHI | 1996-11-18 | 98 |
| K963132 | MINI STRIP/SERUM HCG | JHI | 1996-11-18 | 98 |
| K951705 | MINISTRIP HCG | JHI | 1995-10-03 | 172 |
Recalls
openFDA lists no recalls under a recalling firm named International Newtech Development, 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.
- International Technidyne Corp. (48 510(k)s)
- International Imaging Electronics (19 510(k)s)
- International Biophysics Corp. (14 510(k)s)
- International Medsurg Connection (13 510(k)s)
- International Biomedical (11 510(k)s)
- International Medical Products, Inc. (9 510(k)s)
- International Enzymes, Inc. (7 510(k)s)
- International Medical Industries, Inc. (7 510(k)s)
- International Biomedical, Ltd. (6 510(k)s)
- International Biomedics, Inc. (5 510(k)s)
- International Hospital Supply Co. (5 510(k)s)
- International Regulatory Consultants (5 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under International Newtech Development, Inc.?
FDA lists 8 510(k) clearances under the applicant name “International Newtech Development, Inc.” (first 1995, latest 2000), across 4 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by International Newtech Development, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name International Newtech Development, Inc. is 120 days.
Which FDA product codes appear under International Newtech Development, Inc.?
The most frequent FDA product codes under this applicant name are JHI (Visual, Pregnancy Hcg, Prescription Use, 5); JJX (Single (Specified) Analyte Controls (Assayed And Unassayed), 1); JMT (Diazo (Colorimetric), Nitrite (Urinary, Non-Quant), 1).
Next steps
- See all 8 International Newtech Development, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JHI, International Newtech Development, 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 (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.