Reagent Laboratory, Inc.: FDA filings under this applicant name
FDA lists 19 510(k) clearances under the applicant name “Reagent Laboratory, Inc.” (first 1984, latest 1986), across 13 product codes in 5 review panels. Median 510(k) review time under this name: 41 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 |
|---|---|---|---|
| JIX | Calibrator, Multi-Analyte Mixture | 3 | 3 |
| JJO | Flame Emission Photometer For Clinical Use | 3 | 3 |
| GGK | Products, Red-Cell Lysing Products | 2 | 2 |
| JGS | Electrode, Ion Specific, Sodium | 2 | 2 |
| FNW | Pad, Kelly | 1 | 1 |
| GIF | Diluent, Blood Cell | 1 | 1 |
| IFP | Formalin, Neutral Buffered | 1 | 1 |
| JCC | Ph Buffer | 1 | 1 |
| JJP | Electrode, Ion Selective (Non-Specified) | 1 | 1 |
| JTS | Stains, Microbiologic | 1 | 1 |
Plus 3 more product codes.
Review panels
- Clinical Chemistry (9)
- Pathology (4)
- Hematology (3)
- Microbiology (1)
- General and Plastic Surgery (1)
Most recent Reagent Laboratory, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K863502 | SOLUTION B- NA 50MEQ/L, K 40 MEQ/L | JIX | 1986-10-21 | 42 |
| K863503 | HEMOLYSE | GGK | 1986-10-03 | 24 |
| K863550 | POTASSIUM HYDROXIDE 10% W/V | PPM | 1986-10-02 | 20 |
| K860143 | URINE DILUENT-FOR USE WITH ION SELECTIVE ELECTRODE | JJP | 1986-02-10 | 26 |
| K842982 | FORMALIN BUFFERED | IFP | 1984-10-01 | 63 |
| K843050 | GRAM STAIN | JTS | 1984-09-11 | 39 |
| K842785 | STAIN, METHYLENE BLUE-EOSIN | KFC | 1984-09-11 | 71 |
| K841847 | LITHIUM REAGENT | JJO | 1984-08-17 | 121 |
| K843051 | WRIGHTS STAIN SOLUTION | — | 1984-08-03 | 0 |
| K841800 | LYSING & HEMOGLOBIN REAGENT | GGK | 1984-05-31 | 43 |
9 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Reagent Laboratory, 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.
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.
- Reagent Hospital Prod. , Ltd. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Reagent Laboratory, Inc.?
FDA lists 19 510(k) clearances under the applicant name “Reagent Laboratory, Inc.” (first 1984, latest 1986), across 13 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 Reagent Laboratory, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Reagent Laboratory, Inc. is 41 days.
Which FDA product codes appear under Reagent Laboratory, Inc.?
The most frequent FDA product codes under this applicant name are JIX (Calibrator, Multi-Analyte Mixture, 3); JJO (Flame Emission Photometer For Clinical Use, 3); GGK (Products, Red-Cell Lysing Products, 2).
Next steps
- See all 19 Reagent Laboratory, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JIX, Reagent Laboratory, 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 (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.