Hillcrest Biologicals: FDA filings under this applicant name
FDA lists 33 510(k) clearances under the applicant name “Hillcrest Biologicals” (first 1983, latest 1992), across 23 product codes in 3 review panels. Median 510(k) review time under this name: 94 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 |
|---|---|---|---|
| LSR | Reagent, Borrelia Serological Reagent | 4 | 4 |
| GNK | Antisera, Cf, Echovirus 1-34 | 3 | 3 |
| JSM | Culture Media, Non-Propagating Transport | 3 | 3 |
| GNL | Antigens, Cf (Including Cf Control), Echovirus 1-34 | 2 | 2 |
| GPJ | Antiserum, Fluorescent, Q Fever | 2 | 2 |
| GQC | Antisera, Cf, Equine Encephalitis Virus, Eee, Wee | 2 | 2 |
| GNG | Antigens, Cf (Including Cf Control), Coxsackievirus A 1-24, B 1-6 | 1 | 1 |
| GNO | Antisera, Cf, Coxsackievirus A 1-24, B 1-6 | 1 | 1 |
| GNP | Antiserum, Cf, Epstein-Barr Virus | 1 | 1 |
| GOG | Antisera, Cf, Poliovirus 1-3 | 1 | 1 |
Plus 13 more product codes.
Review panels
- Microbiology (31)
- Dental (1)
- Pathology (1)
Most recent Hillcrest Biologicals 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K913618 | ARBOVIRUS IGM IFA TEST | GQC | 1992-12-03 | 478 |
| K913617 | ARBOVIRUS IGG IFA TEST | GQC | 1992-12-03 | 478 |
| K922374 | Q FEVER IGM IFA TEST | GPJ | 1992-10-21 | 154 |
| K913906 | Q FEVER IGG IFA TEST | GPJ | 1992-10-21 | 418 |
| K900206 | LYME DISEASE IGM ELISA | LSR | 1991-06-28 | 528 |
| K896594 | EBV VCA ANTIBODY (IGM) | LJN | 1990-01-16 | 56 |
| K884829 | EBV EARLY ANTIGEN (R+D) | JRY | 1989-04-12 | 145 |
| K883767 | LYME DISEASE IFA (IGM) | LSR | 1989-03-15 | 190 |
| K884591 | EBV-VCA ANTIBODY (IGG) | GNP | 1989-01-24 | 82 |
| K883487 | LYME DISEASE IFA (IGG) | LSR | 1988-12-13 | 119 |
23 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Hillcrest Biologicals.
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 Hillcrest Biologicals?
FDA lists 33 510(k) clearances under the applicant name “Hillcrest Biologicals” (first 1983, latest 1992), across 23 product codes in 3 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 Hillcrest Biologicals?
The median time from FDA receipt to decision across 510(k)s cleared under the name Hillcrest Biologicals is 94 days.
Which FDA product codes appear under Hillcrest Biologicals?
The most frequent FDA product codes under this applicant name are LSR (Reagent, Borrelia Serological Reagent, 4); GNK (Antisera, Cf, Echovirus 1-34, 3); JSM (Culture Media, Non-Propagating Transport, 3).
Next steps
- See all 33 Hillcrest Biologicals clearances with predicates and recalls
- Run predicate analysis for product code LSR, Hillcrest Biologicals'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.