Sa Scientific, Inc.: FDA clearances and approvals
Sa Scientific, Inc. has 201 FDA 510(k) clearances (first 1993, latest 2013), across 22 product codes in 3 review panels. Median 510(k) review time: 55 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 1 | 24 |
| 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 |
|---|---|---|---|
| GRM | Antisera, All Groups, Salmonella Spp. | 64 | 64 |
| GNC | Antigens, Febrile, Slide And Tube, All Groups, Salmonella Spp. | 49 | 49 |
| GNB | Antisera, All Types, Shigella Spp. | 38 | 38 |
| JHI | Visual, Pregnancy Hcg, Prescription Use | 9 | 9 |
| GSO | Antigens (Febrile), Agglutination, Brucella Spp. | 7 | 7 |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 6 | 6 |
| GSM | Antisera, Fluorescent, Brucella Spp. | 4 | 4 |
| LCX | Kit, Test, Pregnancy, Hcg, Over The Counter | 4 | 4 |
| PSZ | Devices Detecting Influenza A, B, And C Virus Antigens | 4 | 4 |
| GTY | Antigens, All Groups, Streptococcus Spp. | 3 | 3 |
Plus 12 more product codes.
Review panels
- Microbiology (178)
- Clinical Chemistry (22)
- Hematology (1)
Most recent Sa Scientific, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K132352 | SAS FLUALERT A & B, SAS INFLUENZA A TEST | GNX | 2013-08-22 | 24 |
| K100227 | SAS FLUALERT A&B, SAS INFLUENZA A TEST | PSZ | 2010-02-23 | 28 |
| K080380 | SAS INFLUENZA A & B TEST | PSZ | 2009-07-23 | 526 |
| K061496 | SAS LEGIONELLA TEST, SAS LEGIONELLA DIPSTICK TEST | MJH | 2007-06-28 | 393 |
| K041441 | SAS INFLUENZA A TEST | PSZ | 2004-07-22 | 51 |
| K041439 | SAS INFLUENZA B TEST | PSZ | 2004-07-22 | 51 |
| K030628 | SAS RSV CONTROL KIT | JJX | 2003-03-17 | 18 |
| K022845 | SAS RSV TEST | GQG | 2003-01-29 | 155 |
| K022683 | SAS BLOOD/SERUM/URINE/URINE HCG | JHI | 2002-12-16 | 126 |
| K023270 | SAS STREPALERT | GTY | 2002-10-17 | 16 |
191 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Sa Scientific, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of Sa Scientific, Inc.'s product codes (a text match, not an official crosswalk):
Frequently asked questions
How many FDA 510(k) clearances does Sa Scientific, Inc. have?
Sa Scientific, Inc. has 201 FDA 510(k) clearances (first 1993, latest 2013), across 22 product codes in 3 review panels.
How long does FDA take to clear Sa Scientific, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Sa Scientific, Inc.'s cleared 510(k)s is 55 days.
What devices does Sa Scientific, Inc. make?
Its most frequent FDA product codes are GRM (Antisera, All Groups, Salmonella Spp., 64); GNC (Antigens, Febrile, Slide And Tube, All Groups, Salmonella Spp., 49); GNB (Antisera, All Types, Shigella Spp., 38).
Has Sa Scientific, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Sa Scientific, Inc. Related entities may recall under other names.
Next steps
- See all 201 Sa Scientific, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GRM, Sa Scientific, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.