510(k) Report

FDA applicant

Sebia

Norcross, GA34 decisions1995–20240 recalls

FDA records 34 decisions for Sebia (Norcross, GA) from 1995 to 2024: 34 510(k) clearances. Most are in product codes CFF (Immunoelectrophoretic, Immunoglobulins, (G, A…) and GKA (Abnormal Hemoglobin Quantitation). Since 2016 its 510(k)s took a median of 208 days from receipt to decision, against 211 for FDA’s reviews in the same codes and years. Its devices cite 23 predicates, 13 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Sebia, Inc.”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, immunology panel, where it files most

How often FDA has decided Sebia’s devices, and how often a recall has named them.

FDA decisions per year

2in 2024

2007: 22008: 12009: 32010: 22011: 12012: 32013: 12014: 12015: 12016: 12017: 22018: 32019: 22021: 12022: 12024: 2
2007high 3 (2009) · low 0 (2020)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Sebia by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • CFFImmunoelectrophoretic, Immunoglobulins, (G, A, M)8decisions
  • GKAAbnormal Hemoglobin Quantitation7decisions
  • LCPAssay, Glycosylated Hemoglobin3decisions
  • DFHKappa, Antigen, Antiserum, Control3decisions
  • PDJHemoglobin A1c Test System2decisions
  • CEFElectrophoretic, Protein Fractionation2decisions

Also: JKM (2), JJY (2), CFE (2), JHO (1), CIN (1), OBZ (1).

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 208 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 211 days; 2 of its 4 were faster than that.

Whose devices does it build on?

Its devices cite 23 predicates; 13 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 15 times; 13 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K122101Capillarys Hemoglobin HBA1C Capillarys 2 Flex Piercing Capillarys HBA1C Controls Capillarys HBA1C CSebia · 20122cite it
  • K130500Capillarys Immunotyping, Capillarys 2 Instrument, IT/IF Control, Capillarys 2 Flex Piercing InstrumentSebia · 20132cite it
  • K082388Minicap Immunotyping, Model: 2300Sebia · 20091cites it
  • K112491Sebia Capillarys Hemoglobin (E) with Capillarys 2Sebia · 20121cites it
  • K091283Capillarys Neonat HB (PN 2006)Sebia · 20101cites it
  • K161928Capi 3 Immunotyping, Capillarys 3 Tera, IT/IF ControlSebia · 20161cites it

What has FDA decided for it lately?

  • K232027CAPI 3 NEONAT Hb, CAPILLARYS 3 DBS InstrumentSebia · 2024
  • K231601FLC Kappa, FLC Lambda,FLC Control Level 1, FLC Control Level 2Sebia · 2024
  • K210623FLC Kappa, FLC Lambda, FLC Control Level 1, FLC Control Level 2Sebia · 2022
  • K203184HYDRASHIFT 2/4 isatuximabSebia · 2021
  • K192095CAPI 3 Immunotyping, Capillarys 3 TeraSebia · 2019
  • K190851HYDRASHIFT 2/4 daratumumabSebia · 2019
  • K180762Capi 3 Hemoglobin (E)Sebia · 2018
  • K171861CAPILLARYS Hb A1cSebia · 2018

All 32 as Sebia →All 2 as Sebia, Inc. →