# Sebia

- Location (FDA's records): Norcross, GA
- FDA decisions: 34 (1995–2024): 34 510(k) clearances
- Names in FDA's records: Sebia (32); Sebia, Inc. (2)
- Product codes: CFF (8), GKA (7), LCP (3), DFH (3), PDJ (2), CEF (2), JKM (2), JJY (2), CFE (2), JHO (1), CIN (1), OBZ (1)
- 510(k) review time since 2016: median 208 days, against 211 for FDA's reviews in the same codes and years (2 of 4 faster)
- Predicates its devices cite: 23 (13 its own); citations of its devices by later devices: 15 (13 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Tosoh Bioscience, Inc.: 3 (https://510kreport.com/company/tosoh-bioscience)
- Morax: 3 (https://510kreport.com/company/morax)
- The Binding Site, Ltd.: 2 (https://510kreport.com/company/binding-site)
- Canterbury Scientific, Ltd.: 1 (https://510kreport.com/company/canterbury-scientific)
- Beckman Coulter, Inc.: 1 (https://510kreport.com/company/beckman-coulter)

## Firms that cite its devices most
- Helena Laboratories: 1 (https://510kreport.com/company/helena-laboratories)
- Progenika Biopharma S.A., A Grifols Company: 1 (https://510kreport.com/company/progenika-biopharma-sa-a-grifols)

## Its most-cited devices
- K122101: Capillarys Hemoglobin HBA1C Capillarys 2 Flex Piercing Capillarys HBA1C Controls Capillarys HBA1C C (2012), cited by 2
- K130500: Capillarys Immunotyping, Capillarys 2 Instrument, IT/IF Control, Capillarys 2 Flex Piercing Instrument (2013), cited by 2
- K082388: Minicap Immunotyping, Model: 2300 (2009), cited by 1
- K112491: Sebia Capillarys Hemoglobin (E) with Capillarys 2 (2012), cited by 1
- K091283: Capillarys Neonat HB (PN 2006) (2010), cited by 1
- K161928: Capi 3 Immunotyping, Capillarys 3 Tera, IT/IF Control (2016), cited by 1

## Recent decisions
- K232027: CAPI 3 NEONAT Hb, CAPILLARYS 3 DBS Instrument (Apr 4, 2024)
- K231601: FLC Kappa, FLC Lambda,FLC Control Level 1, FLC Control Level 2 (Feb 23, 2024)
- K210623: FLC Kappa, FLC Lambda, FLC Control Level 1, FLC Control Level 2 (Nov 18, 2022)
- K203184: HYDRASHIFT 2/4 isatuximab (Nov 12, 2021)
- K192095: CAPI 3 Immunotyping, Capillarys 3 Tera (Nov 1, 2019)
- K190851: HYDRASHIFT 2/4 daratumumab (May 2, 2019)
- K180762: Capi 3 Hemoglobin (E) (Dec 14, 2018)
- K171861: CAPILLARYS Hb A1c (Feb 7, 2018)

Source page: https://510kreport.com/company/sebia