Remel, L.P.: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Remel, L.P.” (first 1996, latest 1997), across 8 product codes in 1 review panel. Median 510(k) review time under this name: 84 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Thermo Fisher Scientific, based on public ownership records.
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 |
|---|---|---|---|
| JTN | Susceptibility Test Discs, Antimicrobial | 3 | 3 |
| GMP | Antisera, Control For Nontreponemal Tests | 1 | 1 |
| GMQ | Antigens, Nontreponemal, All | 1 | 1 |
| JSM | Culture Media, Non-Propagating Transport | 1 | 1 |
| JSO | Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar | 1 | 1 |
| JTY | Culture Media, For Isolation Of Pathogenic Neisseria | 1 | 1 |
| JTZ | Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth | 1 | 1 |
| JWX | Kit, Screening, Staphylococcus Aureus | 1 | 1 |
Review panels
- Microbiology (10)
Most recent Remel, L.P. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K972359 | REMEL BILE ESCULIN AZIDE AGAR W/6 MCG/ML VANCOMYCIN | JSO | 1997-08-28 | 64 |
| K964315 | REMEL STAPH LATEX KIT | JWX | 1997-02-07 | 101 |
| K964421 | REMEL MEROPENEM 10UG SUSCEPTIBILITY DISK | JTN | 1996-12-06 | 66 |
| K961046 | 10B ARGININE BROTH | JSM | 1996-09-18 | 187 |
| K955143 | RPR LIQUID CONTROLS | GMP | 1996-07-30 | 260 |
| K955136 | RPR CARD TEST KIT | GMQ | 1996-07-29 | 259 |
| K961819 | STREPTOMYCIN DISK (300MCG) | JTN | 1996-07-10 | 61 |
| K961818 | GENTAMICIN DISK (120MCG) | JTN | 1996-07-10 | 61 |
| K960313 | MUELLER HINTON AGAR WITH 2% NACI | JTZ | 1996-03-25 | 63 |
| K954986 | GC BASE W/ 1% GCHI | JTY | 1996-02-16 | 108 |
Recalls
openFDA lists no recalls under a recalling firm named Remel, L.P..
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.
- Remel Co. (154 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Remel, L.P.?
FDA lists 10 510(k) clearances under the applicant name “Remel, L.P.” (first 1996, latest 1997), across 8 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 Remel, L.P.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Remel, L.P. is 84 days.
Which FDA product codes appear under Remel, L.P.?
The most frequent FDA product codes under this applicant name are JTN (Susceptibility Test Discs, Antimicrobial, 3); GMP (Antisera, Control For Nontreponemal Tests, 1); GMQ (Antigens, Nontreponemal, All, 1).
Next steps
- See all 10 Remel, L.P. clearances with predicates and recalls
- Run predicate analysis for product code JTN, Remel, L.P.'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.