Btc Diagnostics, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Btc Diagnostics, Inc.” (first 1983, latest 1984), across 5 product codes in 1 review panel. Median 510(k) review time under this name: 102 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 |
|---|---|---|---|
| CED | 5-Amp-Phosphate Release (Colorimetric Test), 5'-Nucleotidase | 1 | 1 |
| CEP | Radioimmunoassay, Luteinizing Hormone | 1 | 1 |
| JHI | Visual, Pregnancy Hcg, Prescription Use | 1 | 1 |
| JHJ | Agglutination Method, Human Chorionic Gonadotropin | 1 | 1 |
| LCX | Kit, Test, Pregnancy, Hcg, Over The Counter | 1 | 1 |
Review panels
Most recent Btc Diagnostics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K841545 | ENZYME IMMUNOASSAY FOR DETECTION HORM | CEP | 1984-11-27 | 225 |
| K832905 | QUALITATIVE ENZYME IMMUNOASSAY-DETECT | LCX | 1984-02-03 | 158 |
| K833710 | BTC URINE LH ASSAY | CED | 1984-01-30 | 102 |
| K831604 | HCG ACCU-STICK | JHI | 1983-07-19 | 62 |
| K831125 | BTC URINE LCG ASSAY | JHJ | 1983-05-05 | 30 |
Recalls
openFDA lists no recalls under a recalling firm named Btc 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Btc Diagnostics, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Btc Diagnostics, Inc.” (first 1983, latest 1984), across 5 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 Btc Diagnostics, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Btc Diagnostics, Inc. is 102 days.
Which FDA product codes appear under Btc Diagnostics, Inc.?
The most frequent FDA product codes under this applicant name are CED (5-Amp-Phosphate Release (Colorimetric Test), 5'-Nucleotidase, 1); CEP (Radioimmunoassay, Luteinizing Hormone, 1); JHI (Visual, Pregnancy Hcg, Prescription Use, 1).
Next steps
- See all 5 Btc Diagnostics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code CED, Btc 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.