Hazleton Research Products, Inc.: FDA filings under this applicant name
FDA lists 47 510(k) clearances under the applicant name “Hazleton Research Products, Inc.” (first 1985, latest 1986), across 5 product codes in 2 review panels. Median 510(k) review time under this name: 36 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 |
|---|---|---|---|
| KIT | Media And Components, Synthetic Cell And Tissue Culture | 34 | 34 |
| KIS | Sera, Animal And Human | 9 | 9 |
| KIP | Formulations, Balanced Salt Solutions | 2 | 2 |
| JSK | Supplement, Culture Media | 1 | 1 |
Plus 1 more product codes.
Review panels
- Pathology (45)
- Microbiology (1)
Most recent Hazleton Research Products, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K861997 | PENICILLIN-STREPTOMYCIN-FUNGIZONE MIXTURE | JSK | 1986-06-10 | 18 |
| K861996 | DULBECCO'S MEM WITH 4.5 G/L GLUCOSE MEDIUM | KIT | 1986-06-09 | 17 |
| K861887 | MEM GLASGOW POWDERED MEDIUM | KIT | 1986-05-29 | 13 |
| K861886 | DMEM & HAM'S F-12 (1:1) POWDERED MEDIUM | KIT | 1986-05-29 | 13 |
| K861885 | WILLIAMS MEDIUM E POWDER | KIT | 1986-05-29 | 13 |
| K861875 | RPMI-1640 MEDIUM WITH 25MM HEPES BUFFER | KIT | 1986-05-29 | 14 |
| K861874 | MINIMUM ESSENTIAL MED. (EAGLE) W/25MM HEPES BUFFER | KIT | 1986-05-29 | 14 |
| K861873 | MEM GLASGOW MEDIUM | KIT | 1986-05-29 | 14 |
| K861872 | ISCOVE'S (MODIFIED) DULBECCO'S MEDIUM | KIT | 1986-05-29 | 14 |
| K861871 | NCTC 109 MEDIUM | KIT | 1986-05-29 | 14 |
37 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Hazleton Research Products, 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.
- Hazleton Dutchland, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Hazleton Research Products, Inc.?
FDA lists 47 510(k) clearances under the applicant name “Hazleton Research Products, Inc.” (first 1985, latest 1986), across 5 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 Hazleton Research Products, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Hazleton Research Products, Inc. is 36 days.
Which FDA product codes appear under Hazleton Research Products, Inc.?
The most frequent FDA product codes under this applicant name are KIT (Media And Components, Synthetic Cell And Tissue Culture, 34); KIS (Sera, Animal And Human, 9); KIP (Formulations, Balanced Salt Solutions, 2).
Next steps
- See all 47 Hazleton Research Products, Inc. clearances with predicates and recalls
- Run predicate analysis for product code KIT, Hazleton Research Products, 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.