American BriVision (Holding) Corp
Submit a Premarket Notification 510(K) for ABV-2002 to US and Taiwan regulators
Not delivered by the deadline
AI-assessed · human review in progress Found and assessed by AI from the cited sources. Shown with its evidence; it is not counted in any Kept Score until confirmed.
- Announced
- 7 Jan 2021
- Due
- 31 Dec 2021
- Checked
- 25 Oct 2026
- Deadline
- Met
- Late
- Not met
- Today
What the company said
“we intend to submit a Premarket Notification 510(K) submission to the United States and Taiwan FDAs before the end of 2021”
What we found
Evidence strength A What the grades mean
The company continued to state in 2022 filings that it intended to submit the 510(K) before the end of 2021, indicating the deadline passed without the submission occurring.
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A American BriVision (Holding) Corp 10-K filed 2022-03-31
“the Company intends to submit a Premarket Notification 510(K) submission to the FDA before the end of 2021” ✓ confirmed on the page
Market reaction: the shares moved -5.2% against the S&P 500 over the three sessions around the disclosure (30 Mar 2022 to 4 Apr 2022). What this measures
Checked 25 Oct 2026.
Commitment DNA
The structured record of this commitment. Fields the company did not state are left blank rather than guessed.
- Event type
- Regulatory submission
- Indicative materiality
- High rules
- Action
- Submit
- Deliverable
- Premarket Notification 510(K) submission
- Where
- United States and Taiwan
- Language
- Aspirational (“aims”, “intends”)
- In the company’s control
- High
- Specificity
- High
- Depends on
- Regulatory
How this entry was checked
- Commitment recordedThe company's words were matched word for word against the filing.
- First checkAn AI model, Gemini (Google), read the company's later filings and recorded the outcome with a quoted passage.
- Second check: agreesA different AI model, Claude (Anthropic), re-read the evidence without being told the outcome and reached the same answer.
- Third check on a negative finding: disagreesBecause a negative finding could harm a company if wrong, a stronger model re-read the evidence fully blind and read it as “no_evidence”, so a person decides.
Not yet confirmed. Shown on the record, but it will not count in any score until it is confirmed. How verification works
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Report an error in this entry Reference: KI-C-2021-ABVC-021295 · Corrections policy