Tcpi, Inc.: FDA filings under this applicant name
FDA lists 14 510(k) clearances under the applicant name “Tcpi, Inc.” (first 1992, latest 1998), across 12 product codes in 2 review panels. Median 510(k) review time under this name: 117 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 | 2 | 2 |
| LCX | Kit, Test, Pregnancy, Hcg, Over The Counter | 2 | 2 |
| CEP | Radioimmunoassay, Luteinizing Hormone | 1 | 1 |
| DIO | Enzyme Immunoassay, Cocaine And Cocaine Metabolites | 1 | 1 |
| DJG | Enzyme Immunoassay, Opiates | 1 | 1 |
| DKZ | Enzyme Immunoassay, Amphetamine | 1 | 1 |
| JIL | Method, Enzymatic, Glucose (Urinary, Non-Quantitative) | 1 | 1 |
| JIR | Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) | 1 | 1 |
| JMT | Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) | 1 | 1 |
| JXM | Enzyme Immunoassay, Benzodiazepine | 1 | 1 |
Plus 2 more product codes.
Review panels
Most recent Tcpi, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K981363 | ONE STEP URINE DRUG OF ABUSE: PHENCYCLIDINE (PCP) TEST | LCM | 1998-12-22 | 251 |
| K972960 | HEALTH CHECK URI-TEST PROTEIN IN URINE | JIR | 1998-10-07 | 422 |
| K981197 | ONE STEP URINE DRUG OF ABUSE AMPHETAMINE TEST | DKZ | 1998-06-16 | 75 |
| K980776 | ONE STEP URINE DRUG OF ABUSE: BENZODIAZEPINE TEST | JXM | 1998-04-29 | 58 |
| K951853 | ONE STEP URINE DRUG OF ABUSE CANNABINOID TEST (THC) | LDJ | 1996-08-20 | 487 |
| K954968 | HEALTH CHECK URI-TEST GLUCOSE IN URINE TEST | JIL | 1996-07-26 | 273 |
| K954685 | URITEST - NITRITE IN URINE TEST | JMT | 1996-07-22 | 285 |
| K955353 | ONE STEP PREGNANCY HCG SERUN DILUENT REAGENT | JHI | 1996-03-19 | 119 |
| K952096 | ONE STEP URINE DRUG OF ABUSE OPIATE TEST (OPIUM/HEROIN/MORPHINE) | DJG | 1995-08-17 | 105 |
| K951892 | ONE STEP URINE DRUG OF ABUSE COCAINE TEST | DIO | 1995-08-17 | 115 |
4 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Tcpi, 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 Tcpi, Inc.?
FDA lists 14 510(k) clearances under the applicant name “Tcpi, Inc.” (first 1992, latest 1998), across 12 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 Tcpi, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Tcpi, Inc. is 117 days.
Which FDA product codes appear under Tcpi, Inc.?
The most frequent FDA product codes under this applicant name are JHI (Visual, Pregnancy Hcg, Prescription Use, 2); LCX (Kit, Test, Pregnancy, Hcg, Over The Counter, 2); CEP (Radioimmunoassay, Luteinizing Hormone, 1).
Next steps
- See all 14 Tcpi, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JHI, Tcpi, 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.