Phamatech: FDA filings under this applicant name
FDA lists 62 510(k) clearances under the applicant name “Phamatech” (first 1996, latest 2018), across 17 product codes in 2 review panels. Median 510(k) review time under this name: 34 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 | 1 | 450 |
| 2013 | 0 | — |
| 2014 | 1 | 392 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 1 | 90 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Phamatech took a median 90 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 150 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MVO | Kit, Test, Multiple, Drugs Of Abuse, Over The Counter | 14 | 14 |
| DJG | Enzyme Immunoassay, Opiates | 6 | 6 |
| DKZ | Enzyme Immunoassay, Amphetamine | 6 | 6 |
| LCX | Kit, Test, Pregnancy, Hcg, Over The Counter | 5 | 5 |
| DIO | Enzyme Immunoassay, Cocaine And Cocaine Metabolites | 4 | 4 |
| LAF | Gas Chromatography, Methamphetamine | 4 | 4 |
| LCM | Enzyme Immunoassay, Phencyclidine | 4 | 4 |
| DIS | Enzyme Immunoassay, Barbiturate | 3 | 3 |
| JHI | Visual, Pregnancy Hcg, Prescription Use | 3 | 3 |
| LDJ | Enzyme Immunoassay, Cannabinoids | 3 | 3 |
Plus 7 more product codes.
Review panels
- Clinical Toxicology (50)
- Clinical Chemistry (12)
Most recent Phamatech 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K181945 | QuickScreen Pro Multi Drug Screening Test, Model 9395Z | DKZ | 2018-10-18 | 90 |
| K131069 | QUICKSCREEN AMPHETINE 500 TEST | DKZ | 2014-05-14 | 392 |
| K103295 | QUICKSCREEN COCAINE 150 SCREENING TEST | DIO | 2012-02-01 | 450 |
| K070098 | QUICKSCREEN BARBITURATE 300 SCREENING TEST, MODELS 9019, 9018; MULTI DRUG SCREENING TEST, MODEL 9317T; CUP MULTI DRUG SC | DIS | 2007-12-07 | 331 |
| K070009 | AT HOME DRUG TEST MODELS, 9308T AND 9308X | DIS | 2007-12-07 | 338 |
| K043599 | MOMENTS MENOPAUSE CHECK, MODEL 9113 | CGJ | 2005-02-25 | 58 |
| K043051 | QUICKSCREEN OXYCODONE TEST, MODELS 9120, 9120T, 9120X AND 9121 | DJG | 2005-02-07 | 95 |
| K043167 | PHAMATECH QUICKSCREEN BENZODIAZEPINES TEST, MODELS 9025, 9026, 9027T, 9153T AND 9195X | JXM | 2004-12-29 | 43 |
| K041578 | QUICKSCREEN, MODELS 9177X AND 9178X | LCM | 2004-09-10 | 88 |
| K040575 | PHARMATECH MENOPAUSE CHECK, MODELS 9111 AND 9112 | CGJ | 2004-05-20 | 77 |
52 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Phamatech.
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 Phamatech?
FDA lists 62 510(k) clearances under the applicant name “Phamatech” (first 1996, latest 2018), across 17 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 Phamatech?
The median time from FDA receipt to decision across 510(k)s cleared under the name Phamatech is 34 days.
Which FDA product codes appear under Phamatech?
The most frequent FDA product codes under this applicant name are MVO (Kit, Test, Multiple, Drugs Of Abuse, Over The Counter, 14); DJG (Enzyme Immunoassay, Opiates, 6); DKZ (Enzyme Immunoassay, Amphetamine, 6).
Next steps
- See all 62 Phamatech clearances with predicates and recalls
- Run predicate analysis for product code MVO, Phamatech'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.