SLSBIO CO LTD · 89-08 · KOREA (THE REPUBLIC OF)
For SLSBIO CO LTD · 89-08 · KOREA (THE REPUBLIC OF), import alert is 89-08; import alert name is "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"; country is KOREA (THE REPUBLIC OF); product is SsmarTest COVID-19 IgM/IgG Detection Kit | SsmarTest COVID-19 IgM/IgG Detection Kit | SsmarTest COVID-19 IgM/IgG Detection Kit | SsmarTest COVID-19 IgM/IgG Detection Kit; product code is 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid | 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KP Coronavirus antigen detection test system. | 83 Q - - LT COVID-19 multi-analyte respiratory panel nucleic acid devices; date published is 10/21/2020; address is Gwanggyo Central Biz To , Suwon, KOREA (THE REPUBLIC OF), verified against its source on 2026-09-16.
- Firm
- SLSBIO CO LTD verified
- Import alert
- 89-08
- Import alert name
- "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"
- Country
- KOREA (THE REPUBLIC OF) verified
- Address
- Gwanggyo Central Biz To , Suwon, KOREA (THE REPUBLIC OF) verified
- Date published
- 10/21/2020 verified
- Product code
- 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid | 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KP Coronavirus antigen detection test system. | 83 Q - - LT COVID-19 multi-analyte respiratory panel nucleic acid devices each item verified
- Product
- SsmarTest COVID-19 IgM/IgG Detection Kit | SsmarTest COVID-19 IgM/IgG Detection Kit | SsmarTest COVID-19 IgM/IgG Detection Kit | SsmarTest COVID-19 IgM/IgG Detection Kit each item verified
What the source says
SLSBIO CO LTD Date Published : 10/21/2020 Gwanggyo Central Biz To , Suwon, KOREA (THE REPUBLIC OF) 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid Date Published: 10/21/2020 Desc: SsmarTest COVID-19 IgM/IgG Detection Kit 83 Q - - KO Reagent, coronavirus serological Date Published: 10/21/2020 Desc: SsmarTest COVID-19 IgM/IgG Detection Kit 83 Q - - KP Coronavirus antigen detection test system. Date Published: 10/21/2020 Desc: SsmarTest COVID-19 IgM/IgG Detection Kit 83 Q - - LT COVID-19 multi-analyte respiratory panel nucleic acid devices Date Published: 10/21/2020 Desc: SsmarTest COVID-19 IgM/IgG Detection Kit
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html