J.S. Medical Assoc.: FDA filings under this applicant name
FDA lists 20 510(k) clearances under the applicant name “J.S. Medical Assoc.” (first 1983, latest 2002), across 14 product codes in 5 review panels. Median 510(k) review time under this name: 96 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 |
|---|---|---|---|
| JMO | Ferrozine (Colorimetric) Iron Binding Capacity | 3 | 3 |
| KTN | System, Test, Infectious Mononucleosis | 3 | 3 |
| DHR | System, Test, Rheumatoid Factor | 2 | 2 |
| HYF | Giemsa Stain | 2 | 2 |
| DCK | C-Reactive Protein, Antigen, Antiserum, And Control | 1 | 1 |
| DCN | System, Test, C-Reactive Protein | 1 | 1 |
| GTQ | Antistreptolysin - Titer/Streptolysin O Reagent | 1 | 1 |
| IAF | Wright'S Stain | 1 | 1 |
| JHJ | Agglutination Method, Human Chorionic Gonadotropin | 1 | 1 |
| JJW | Urinalysis Controls (Assayed And Unassayed) | 1 | 1 |
Plus 4 more product codes.
Review panels
- Clinical Chemistry (6)
- Immunology (5)
- Microbiology (5)
- Pathology (3)
- Ear, Nose and Throat (1)
Most recent J.S. Medical Assoc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K022085 | J&S MEDICAL SENTRY URINE DIPSTICK CONTROL | JJW | 2002-07-25 | 28 |
| K932752 | VISI-SPOT | JTO | 1993-11-05 | 170 |
| K932688 | EYE SPOT IM TEST | KTN | 1993-09-08 | 97 |
| K932437 | EYE SPOT RF TEST | DHR | 1993-08-23 | 96 |
| K932180 | EYE SPOT CRP TEST | DCN | 1993-08-23 | 110 |
| K932551 | ACCUTEX IM LATEX TEST | KTN | 1993-08-09 | 75 |
| K926112 | ACCUTEX BETA-HCG TEST | JHJ | 1993-07-28 | 237 |
| K924332 | ACCUTEX CRP LATEX TEST | DCK | 1992-12-07 | 102 |
| K924247 | ACCUTEX ASO LATEX TEST | GTQ | 1992-12-07 | 105 |
| K924036 | ACCUTEX RHEUMATIOD FACTOR (RF) LATEX TEST | DHR | 1992-12-01 | 112 |
10 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named J.S. Medical Assoc..
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 J.S. Medical Assoc.?
FDA lists 20 510(k) clearances under the applicant name “J.S. Medical Assoc.” (first 1983, latest 2002), across 14 product codes in 5 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 J.S. Medical Assoc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name J.S. Medical Assoc. is 96 days.
Which FDA product codes appear under J.S. Medical Assoc.?
The most frequent FDA product codes under this applicant name are JMO (Ferrozine (Colorimetric) Iron Binding Capacity, 3); KTN (System, Test, Infectious Mononucleosis, 3); DHR (System, Test, Rheumatoid Factor, 2).
Next steps
- See all 20 J.S. Medical Assoc. clearances with predicates and recalls
- Run predicate analysis for product code JMO, J.S. Medical Assoc.'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.