secwatch.observer — SEC 8-K summary
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Issuer:     Bluejay Diagnostics, Inc. (BJDX)
CIK:        0001704287
Form:       8-K
Filed at:   2026-10-13T13:09:40+00:00
Accession:  0001213900-26-108779
Event type: other_material
Sentiment:  positive
Materiality: 0.45
Item codes: 7.01, 9.01
LLM model:  deepseek-v4.1-flash:cloud@v2

Bluejay completes Toray manufacturing-site milestone ahead of Oct 23 deadline
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- Bluejay formally notified Toray Industries it substantially completed establishment of a Symphony cartridge manufacturing site, ahead of the October 23, 2026 contractual deadline.
- Manufacturing split across SanyoSeiko Co., Ltd. in Japan (the site under the Toray agreement) and ALURIS Sciences, formerly Argonaut Manufacturing Services, in the U.S.
- Symphony IL-6 Test, the first product candidate, is not FDA cleared or approved and remains limited to investigational use in the U.S.; no financial terms disclosed.
- Regulatory path runs through the SYMON studies: SYMON-I (NCT06181604), pivotal SYMON-II (NCT06654895) to support a 510(k), and SYMON-III (NCT07425587).

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1704287/000121390026108779/0001213900-26-108779-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1704287/000121390026108779/ea0308401-8k_bluejay.htm
  HTML page:      https://secwatch.observer/filing/0001213900-26-108779

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