Sita, Inc.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Sita, Inc.” (first 1987, latest 1987), across 6 product codes in 1 review panel. Median 510(k) review time under this name: 73 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 |
|---|---|---|---|
| GQT | Antisera, Cf, Parainfluenza Virus 1-4 | 3 | 3 |
| GNW | Antisera, Cf, Influenza Virus A, B, C | 2 | 2 |
| GOA | Antisera, Cf, Adenovirus 1-33 | 1 | 1 |
| GPW | Antigen, Cf, Psittacosis (Chlamydia Group) | 1 | 1 |
| GRB | Antiserum, Cf, Mumps Virus | 1 | 1 |
| LKT | Respiratory Syncytial Virus, Antigen, Antibody, Ifa | 1 | 1 |
Review panels
- Microbiology (9)
Most recent Sita, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K872700 | YHLAMYDIA CF ANTIGEN AND CONTROL ANTIGEN | GPW | 1987-10-15 | 100 |
| K872701 | RESPIRATORY SYNCYTIAL VIRUS CF ANTIGEN & CONTROL | LKT | 1987-09-18 | 73 |
| K872699 | MUMPS CF ANTIGEN AND CONTROL ANTIGEN | GRB | 1987-09-18 | 73 |
| K872698 | ADENOVIRUS CF ANTIGEN AND CONTROL ANTIGEN | GOA | 1987-09-18 | 73 |
| K872697 | PARAINFLUENZA-I-CF ANTIGEN AND CONTROL ANTIGEN | GQT | 1987-09-18 | 73 |
| K872696 | PARAINFLUENZA-3-CF ANTIGEN AND CONTROL ANTIGEN | GQT | 1987-09-18 | 73 |
| K872695 | PARAINFLUENZA-2-CF ANTIGEN AND CONTROL ANTIGEN | GQT | 1987-09-18 | 73 |
| K872694 | YNFLUENZA A VIRUS CF ANTIGEN AND CONTROL ANTIGEN | GNW | 1987-09-18 | 73 |
| K872693 | INFLUENZA B VIRUS CF ANTIGEN AND CONTROL ANTIGEN | GNW | 1987-09-18 | 73 |
Recalls
openFDA lists no recalls under a recalling firm named Sita, 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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Sita, Inc. (a text match, not an official crosswalk):
- G0008 — Administration of influenza virus vaccine (via GNW)
- Q2039 — Influenza virus vaccine, not otherwise specified (via GNW)
- Q2034 — Influenza virus vaccine, split virus, for intramuscular use (agriflu) (via GNW)
Frequently asked questions
How many FDA 510(k) clearances are listed under Sita, Inc.?
FDA lists 9 510(k) clearances under the applicant name “Sita, Inc.” (first 1987, latest 1987), across 6 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 Sita, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Sita, Inc. is 73 days.
Which FDA product codes appear under Sita, Inc.?
The most frequent FDA product codes under this applicant name are GQT (Antisera, Cf, Parainfluenza Virus 1-4, 3); GNW (Antisera, Cf, Influenza Virus A, B, C, 2); GOA (Antisera, Cf, Adenovirus 1-33, 1).
Next steps
- See all 9 Sita, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GQT, Sita, 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.