Pyramid Biological Corp.: FDA filings under this applicant name
FDA lists 12 510(k) clearances under the applicant name “Pyramid Biological Corp.” (first 1993, latest 1997), across 7 product codes in 2 review panels. Median 510(k) review time under this name: 129 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 |
|---|---|---|---|
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 3 | 3 |
| GOM | Antisera, Cf, Rubella | 2 | 2 |
| GQI | Antiserum, Cf, Cytomegalovirus | 2 | 2 |
| LIP | Enzyme Linked Immunoabsorption Assay, Treponema Pallidum | 2 | 2 |
| GMM | Antigens, Iha, Toxoplasma Gondii | 1 | 1 |
| LYR | Helicobacter Pylori | 1 | 1 |
| MJY | Kit, Serological, Negative Control | 1 | 1 |
Review panels
- Microbiology (9)
- Clinical Chemistry (3)
Most recent Pyramid Biological Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K964675 | H.PYLORI CONTROLS | LYR | 1997-01-27 | 67 |
| K962399 | HEPATITIS NEGATIVE CONTROL | MJY | 1996-08-02 | 42 |
| K961317 | SYPHILIS IGM HUMAN SERUM CONTROLS | LIP | 1996-06-24 | 80 |
| K960493 | SYPHILIS IGG HUMAN SERUM CONTROLS | LIP | 1996-06-17 | 137 |
| K954515 | ENZYME LINKED IMMUNOABSORBENT ASSAY, RUBELLA | GOM | 1995-12-20 | 83 |
| K953826 | ENZYME LINKED UMMINOABSORBENT ASSAY, RUBELLA | GOM | 1995-12-14 | 121 |
| K952818 | ENZYME LINKED IMMUNOABSORBENT ASSAY, TOXOPLASMA GONDII | GMM | 1995-11-20 | 153 |
| K952254 | ENZYME LINKED IMMUNOABSORBENT ASSAY, CYTOMEGALOVIRUS | GQI | 1995-11-16 | 185 |
| K951800 | CMV IGG HUMAN SERUM CONTROLS | GQI | 1995-11-16 | 212 |
| K944515 | SERUM PROTEIN CONTROLS | JJX | 1994-11-17 | 63 |
2 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Pyramid Biological Corp..
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.
- Pyramid (2 510(k)s)
- Pyramid Air Systems (1 510(k)s)
- Pyramid Handbags, Inc. (1 510(k)s)
- Pyramid Medical, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Pyramid Biological Corp.?
FDA lists 12 510(k) clearances under the applicant name “Pyramid Biological Corp.” (first 1993, latest 1997), across 7 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 Pyramid Biological Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Pyramid Biological Corp. is 129 days.
Which FDA product codes appear under Pyramid Biological Corp.?
The most frequent FDA product codes under this applicant name are JJX (Single (Specified) Analyte Controls (Assayed And Unassayed), 3); GOM (Antisera, Cf, Rubella, 2); GQI (Antiserum, Cf, Cytomegalovirus, 2).
Next steps
- See all 12 Pyramid Biological Corp. clearances with predicates and recalls
- Run predicate analysis for product code JJX, Pyramid Biological Corp.'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.